JP7044374B2 - Extraction device - Google Patents

Description

The present disclosure relates generally to implants placed within the gastrointestinal system, including the esophagus, stomach and intestines. More specifically, the present disclosure has implantable and removable components using endoscopic techniques to treat obesity, diabetes, reflux disease, gastroparesis and other gastrointestinal conditions. With respect to equipment and methods for the extraction system.

Obesity surgery such as sleeve gastrectomy, Roux-en-Y gastric bypass (RYGB) and bileo-pancreative division (BPD) to achieve weight loss in obese patients To correct food intake and / or absorption in the gastrointestinal system. These operations short-circuit certain natural pathways or cause various interactions between the food ingested, the gastrointestinal tract and its secretions, and the neurohormonal system that regulates food intake and metabolism. Either of these affects the metabolic processes in the gastrointestinal system. In the last few years, there is a clinical agreement that obese patients who have undergone obesity surgery will have a marked resolution of type 2 diabetes (T2DM: type-2 Diabetes Mellitus) immediately after surgery. A prominent solution to diabetes after RYGB and BPD usually cannot be explained by weight loss alone because it occurs too early, suggesting that it can directly affect glucose homeostasis. The mechanism of this solution for T2DM has not been fully elucidated and it is likely that multiple mechanisms are involved.

One of the drawbacks of obesity surgery is that obesity surgery requires highly invasive surgery, can cause serious complications, and has a long patient recovery period. In recent years, there has been an increasing effort to develop surgery that is similar in effectiveness to obesity surgery and is minimally invasive. One such operation involves the use of gastrointestinal implants that modify the transfer and absorption of food and organ secretions. For example, (Patent Document 1) describes an implant having a tubular sleeve with a fixed spine, which physically limits the degree of freedom and can be easily removed or replaced. Can not. In addition, stents with active fixation means such as spines that penetrate deep into the surrounding tissue cause tissue necrosis and corrosion of implants that have entered the tissue, which can lead to complications such as bacterial or systemic infections of mucosal tissue. there is a possibility. Also, implants such as stents tend to move due to intermittent peristaltic movements in the gastrointestinal tract.

U.S. Pat. No. 7,476,256

An object of the present invention is to provide an extraction device capable of solving the above-mentioned problems.

In the present specification, a take-out device for taking out a foreign substance from the inside of a patient is described. The unloading device includes a mounting assembly that includes a mounting cable with a restraining mechanism and a mounting cable sheath. The unloading device also has a capsule, a capsule sheath, a first end attached to the second end of the capsule sheath, and a second end with a cable assembly lock, the first end and the first end. Includes a capsule assembly that includes a handle that defines the length between the second end and the second end. The handle also has a stretching mechanism configured to stretch the handle, whereby in the first configuration, the first end of the handle is separated from the second end of the handle by a first distance. , In the second configuration, the first end of the handle is separated from the second end of the handle by a second distance. The inner diameter of the capsule, capsule sheath and handle is sized to accommodate the outer diameter of the mounting assembly, and the cable assembly lock is configured to engage the restraining mechanism of the mounting assembly, thereby the mounting assembly. It is prevented from moving longitudinally with respect to the handle.

Also disclosed herein is a withdrawal system for withdrawing a medical device from inside a patient. The withdrawal system includes a connecting assembly that includes an elongated wire with a connecting mechanism, a wire lock, and a restraining mechanism. The extraction device also has a wire lumen having a first end, a second end, an inner diameter and an outer diameter, the second end configured to engage the wire lock. Demarcating the inner surface of the wire, the wire lumen is configured to receive the first end of the elongated wire. The extraction device also has a collection mechanism that includes an extraction lumen, an extraction tube, and a tension system, where the tension system measures the length of the first and second ends of the tension system from each other. It is configured to stretch. The connecting assembly is configured to be accepted within the recovery mechanism, and the tension system clamp is configured to prevent longitudinal movement of the elongated wire with respect to the second end of the tension system, resulting in it. By extending the length of the first and second ends of the tension system from each other, the first end of the elongated wire is taken out and pulled into the first end of the cavity.

Also disclosed herein are methods of withdrawing a foreign body from the patient's body. The method is to insert the wire assembly into the patient, the wire assembly comprising the wire in a wire tube, the wire having a first end and a second end having a mounting device, insertion. By attaching the wire attachment device to a foreign object and advancing the recovery sheath surrounding the wire assembly into the patient's body, the recovery sheath is a first open end, a length portion, and a wire lock. Includes advancing with a second end having a mechanism. The method also secures the wire locking mechanism to the second end of the wire and extends the length of the recovery sheath so that the wire assembly and foreign matter are drawn into the first opening end of the recovery sheath, and the patient. Includes removing the recovery pod with a foreign body in the body.

Also disclosed herein is a method of removing a gastrointestinal device from a patient with a drawstring, an expandable proximal flange and an distal flange. The method comprises inserting the hook assembly into the patient, the hook assembly comprising a first end, a second end, and a hook cable having a hook, the hook cable inside the hook sheath. Accepted. The method also attaches the hook to the pull string of the gastrointestinal device and pulls the hook cable into the first end of the hook sheath to collapse the expandable proximal flange and pulls the pull string into the hook sheath. Retracting to the first end and advancing the capsule assembly covering the hook assembly into the patient's body, the capsule assembly is the first end with the capsule, the length portion, and the second. Includes advancing, having an end of the. The method also secures the second end of the hook assembly to the second end of the capsule and the first end of the hook assembly and the collapsed base flange to the first end of the capsule assembly. Stretching the capsule assembly to retract and advancing the second end of the hook assembly to cover the tip flange of the gastrointestinal device so that the tip flange is accommodated within the first end of the capsule assembly. Includes retrieving the capsule assembly containing the gastrointestinal device from the patient.

Also disclosed herein is a removal system that withdraws the implant from the patient's body. The withdrawal system includes an insertion assembly configured to be at least partially inserted into the patient's body. The insertion assembly includes a capsule having a length, inner diameter and outer diameter, and an elongated lumen connected to the capsule, the elongated lumen with the first end attached to the sheath. , With a second end and a length portion in between, the elongated lumen is configured to be minimally compressible along the length. The withdrawal system also includes a handle assembly that is coupled to the second end of the elongated lumen and is configured to be placed outside the patient's body and includes a threading mechanism. The threading mechanism is configured to apply mechanical force to the insertion assembly, which transmits mechanical force to crush the implant from a larger expansion configuration to a smaller reduction configuration, and the implant is encapsulated inside diameter. It is configured to be accepted within the department.

Also disclosed herein is a removal system for taking a self-expandable stent from the patient's body. The withdrawal system is a threaded handle mechanism configured to transfer the mechanical force required to crush and accept the protective capsule and the self-expandable stent in the protective capsule from a larger expandable configuration to a smaller collapsed configuration. Includes a minimally compressible catheter assembly that is attached to the protective capsule and threaded handle and configured to remotely transfer mechanical force from the threaded handle to the protective capsule.

Also disclosed herein are unloading devices, including hook assemblies and capsule assemblies. The hook assembly has a first end, a second end, and a length portion in between. The hook assembly has a mounting feature at the first end. The capsule assembly includes a capsule, a capsule shaft and a handle that are connected in series and define an inner peripheral hole along the length of the capsule assembly along the central longitudinal axis. The capsule has a first end that defines an opening into the capsule. The inner peripheral hole of the capsule assembly is configured to slidably accept the hook assembly. The handle defines a central portion, a first extension portion having a first end attached to the capsule shaft and a first end portion of the handle, and a second end portion of the handle. It has a second extension with two ends. The second extension has a hook assembly lock at the second end. The handle has a storage configuration in which the first end is at a first distance from the second end along the central longitudinal axis, and the first end is from the second end along the central longitudinal axis. It has an extended configuration at a distance of two. The hook assembly lock is configured to lock the hook assembly to the second extension. The second extension is configured to pull the hook assembly against the capsule shaft along the central longitudinal axis, and the first extension is configured to push the capsule shaft against the hook assembly along the central longitudinal axis. It is composed of.

Also disclosed herein is a take-out device that removes an object from the patient's body. The unloading device includes a hook assembly and a capsule assembly. The hook assembly includes a sheath having a first end, a second end, and a wall extending between the first end and the second end and defining a lumen between them. .. The hook assembly also includes a cable having a mounting feature at the first end. The cable is configured to be slidably accepted into the lumen of the sheath. The second end of the cable is configured to be locked to the second end of the sheath to prevent longitudinal movement of the cable with respect to the sheath. The capsule assembly includes a capsule, a capsule shaft and a handle that are connected in series and define an inner peripheral hole along the length of the capsule assembly. The capsule has a first end that defines an opening into the capsule. The handle attaches the hook assembly to the second end of the handle so that the first end, the second end, and the hook assembly are prevented from moving relative to the second end of the handle. Has a hook assembly lock and is configured to lock into. The handle has a retracted configuration in which the first end is at a first distance from the second end and an extended configuration in which the first end is at a second distance from the second end. The inner peripheral hole of the capsule assembly is configured to slideably accept the hook assembly along the central longitudinal axis. By shifting the handle between the retracted and extended configurations, the hook assembly slides along the central longitudinal axis with respect to the capsule shaft.

Also disclosed herein are methods of withdrawing a medical device from within a patient. The method involves inserting the mounting assembly into the patient's body. The mounting assembly includes a mounting cable with a first end having mounting features and a second end. The method comprises connecting the mounting feature to a medical device placed within the patient's body and advancing the capsule assembly into the patient's body with the capsule assembly surrounding the mounting assembly. The capsule assembly has a capsule at the first end and a handle having a second end and defining a second end of the capsule assembly. The method comprises locking the second end of the mounting cable to the second end of the handle. The method also involves transitioning the handle from a collapsed configuration to an extended configuration so that the handle pulls the mounting assembly through the capsule assembly and the mounting feature is pulled into the capsule, and the capsule assembly and mounting assembly coupled to the medical device. Includes removal from the patient's body.

Although a plurality of embodiments will be disclosed, yet yet another embodiment of the invention will be apparent to those skilled in the art from the following detailed description illustrating and illustrating exemplary embodiments of the invention. Therefore, the drawings and detailed description should be considered as illustrative in nature and not limiting.

FIG. 6 is a cross-sectional view of a portion of the gastrointestinal tract of the human body in which an anchor is placed in the pylorus and a sleeve is attached to the anchor according to some embodiments. FIG. 6 is a cross-sectional view of a portion of the gastrointestinal tract of the human body in which an anchor is placed in the pylorus and a sleeve is attached to the anchor according to some embodiments. It is a cross-sectional view of a part of the gastrointestinal tract of the human body in which the anchor is embedded in the pylorus, and shows the structure of the anchor according to some embodiments. It is a schematic diagram of an anchor and a sleeve by some embodiments. It is a schematic diagram of an anchor and a sleeve by some embodiments. It is a schematic diagram of the anchor by some embodiments. It is a schematic diagram of the anchor of the collapse structure by some embodiments. It is an overall schematic diagram of the extraction system by various aspects of this disclosure. FIG. 3 is an overall schematic of a mounting assembly according to various aspects of the present disclosure. It is an overall schematic view of the mounting assembly according to various aspects of the present disclosure, and shows the sectional view. FIG. 9 is a side view of a hook that can be used in the mounting assembly of FIGS. 9A and 9B according to various aspects of the present disclosure. FIG. 3 is an overall schematic representation of a capsule assembly according to various aspects of the present disclosure. FIG. 3 is a perspective view of a capsule according to various aspects of the present disclosure. FIG. 6 is a side view including a partially broken view of the capsule shown in FIG. 11A according to various aspects of the present disclosure. 11A is an end view of a portion of the capsule shown in FIG. 11A, according to various aspects of the present disclosure. It is a side view of a part of the capsule shown in FIG. 11A according to various aspects of the present disclosure. 11A is an end view of a portion of the capsule shown in FIG. 11A, according to various aspects of the present disclosure. It is a side view of a part of the capsule shown in FIG. 11A according to various aspects of the present disclosure. 11A is an end view of a portion of the capsule shown in FIG. 11A, according to various aspects of the present disclosure. It is a side view of a part of the capsule shown in FIG. 11A according to various aspects of the present disclosure. FIG. 3 is a side view of various exemplary features that can be used in capsules according to the various aspects of the present disclosure. FIG. 3 is a side view of various exemplary features that can be used in capsules according to the various aspects of the present disclosure. FIG. 3 is a side view of various exemplary features that can be used in capsules according to the various aspects of the present disclosure. FIG. 3 is a side view of various additional exemplary features that can be used in capsules, according to various aspects of the present disclosure. FIG. 3 is a side view of various additional exemplary features that can be used in capsules, according to various aspects of the present disclosure. FIG. 3 is a perspective view of various additional exemplary features that can be used in capsules, according to various aspects of the present disclosure. FIG. 3 is a perspective view of various additional exemplary features that can be used in capsules, according to various aspects of the present disclosure. FIG. 3 is a side view of an exemplary tip tool that can be used in a capsule at various steps of deployment, according to various aspects of the present disclosure. FIG. 3 is a side view of an exemplary tip tool that can be used in a capsule at various steps of deployment, according to various aspects of the present disclosure. FIG. 3 is a side view of an exemplary tip tool that can be used in a capsule at various steps of deployment, according to various aspects of the present disclosure. FIG. 3 is an overall schematic representation of a handle assembly showing a particular internal feature according to various aspects of the present disclosure. FIG. 3 is an overall schematic representation of a handle assembly showing a particular internal feature according to various aspects of the present disclosure. FIG. 3 is an overall schematic view of a lock portion showing a specific internal feature portion according to various aspects of the present disclosure. FIG. 3 is a schematic diagram of a locking portion showing a particular internal feature portion according to various aspects of the present disclosure. FIG. 3 is an overall view of a reduced configuration handle according to various aspects of the present disclosure. FIG. 3 is an overall view of a handle in an extended configuration according to various aspects of the present disclosure. It is a figure which shows the development step in the extraction method using the disclosed apparatus by various aspects of this disclosure. It is a figure which shows the development step in the extraction method using the disclosed apparatus by various aspects of this disclosure. It is a figure which shows the development step in the extraction method using the disclosed apparatus by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. It is a figure which shows the development step in the extraction method by various aspects of this disclosure. The deployment steps in the extraction method according to various aspects of the present disclosure are shown. The deployment steps in the extraction method according to various aspects of the present disclosure are shown. The deployment steps in the extraction method according to various aspects of the present disclosure are shown. The deployment steps in the extraction method according to various aspects of the present disclosure are shown. The deployment steps in the extraction method according to various aspects of the present disclosure are shown.

It will be readily apparent to those skilled in the art that various aspects of the present disclosure can be achieved by any number of methods and devices configured to perform the intended function. It should be noted that the accompanying drawings referred to herein are not necessarily drawn to a certain scale and may be exaggerated to show various aspects of the present disclosure, in connection with which the drawings may be exaggerated. , Should not be construed as limiting.

The present disclosure relates to a system and method of placing and / or removing the device from the patient's body. Using the systems and methods disclosed herein, the device can be endoscopically implanted in the patient's body through the mouth, throat, stomach and intestines and / or removed from the patient's body. .. Some examples place the device in the patient's gastrointestinal tract, such as in the patient's pyloric antrum, pylorus, duodenum and / or jejunum when the device is attached to the catheter, and / or from within the patient's gastrointestinal tract. Regarding the extraction system and method.

In some examples, using the systems and methods disclosed herein, devices such as gastrointestinal devices are placed in the patient's stomach, intestine, pyloric antrum, pylorus, duodenum or jejunum, and / or they. It can be taken out from inside. The systems and methods disclosed herein can be used to remove devices with extended and collapsed configurations from within the patient's gastrointestinal tract. For example, the systems and methods disclosed herein can be used to place the device in a collapsed configuration inside the patient and transfer the device to an extended configuration to hold the device inside the patient. The systems and methods disclosed herein can be used to move the device into a collapsed configuration and pull the device out of the patient's interior to remove the device within the patient's body in an extended configuration.

FIG. 1 shows a cross-sectional view of a portion of the human gastrointestinal tract 10 showing the stomach 16 and the intestine 18. As shown in FIG. 1, the gastrointestinal device 100 can be placed between the stomach 16 and the intestine 18. The gastrointestinal device 100 can be placed in the pylorus 20 and a portion of the gastrointestinal device 100 is configured to be placed in the pyloric antrum 22. The gastrointestinal device 100 can be arranged with specific parts of the gastrointestinal device 100 placed in the stomach 16, the pylorus 20, and the intestine 18.

FIG. 2 is a cross-sectional view of a portion of the patient's gastrointestinal tract, showing the pylorus 20, the pyloric antrum 22, the duodenum 24 and the duodenal bulb 26. FIG. 2 shows that the gastrointestinal device 100 is located between the stomach 16 and the intestine 18. As shown in FIG. 2, the gastrointestinal device 100 can include an anchor 110 that holds or holds the gastrointestinal device 100 in place when placed in the patient's body, and a sleeve 120 attached to the anchor 110. .. The gastrointestinal device 100 can be an implant, a gastrointestinal implant or a pyloric implant. Upon deployment, the anchor 110 of the gastrointestinal device 100 transitions to an expanded configuration and can hold the gastrointestinal device 100 in place after implantation. In some examples, upon deployment, the sleeve 120 can be placed within the patient's intestine 18. The sleeve 120 of the gastrointestinal device 100 shown within the intestine 18 can be an intestinal sleeve, a bypass sleeve such as an intestinal bypass sleeve, an intestinal liner or a bypass liner. The sleeve 120 can be designed to be placed within the duodenum 24 from the pylorus 20 to the Tritz ligament when unfolded. When deployed within the patient, the sleeve 120 is held in place within the intestine 18 by the anchor 110 of the gastrointestinal device 100 placed in or in contact with the pylorus 20.

FIG. 3 shows a side view of the anchor 110. As shown in FIG. 3, the anchor 110 has an overall cylindrical shape with a longitudinal length of 30 and a radial width of 32. In some embodiments, the anchor 110 defines a central longitudinal axis along the length 30 of the anchor 110. The anchor 110 has a base end portion 130, a tip end portion 132 and a neck portion 134.

In some embodiments, the proximal portion 130 is circular or disc shaped. In a further example, the proximal portion 130 has a proximal portion 140, a distal end 142 and an outer wall in between. In some examples, the proximal end 140 and the distal end 142 define an overall cylindrical or tubular shape. In some embodiments, the proximal portion 130 comprises a proximal flange wall 148. The proximal flange wall 148 is molded as a disc and attached to the distal end 142 of the proximal portion 130. The proximal flange wall 148 is oriented so as to intersect the central longitudinal axis of the anchor 110. The distal end 142 and / or the proximal flange wall 148 of the proximal portion 130 may be concave, for example, the proximal flange wall 148 may resemble a bowl. When placed inside the patient, the proximal portion 130 can be placed on the side of the pylorus 20 within the stomach 16. In the extended configuration, the base end portion 130 can be opened to allow the chyme to flow in. That is, the proximal end portion 130 has an overall cylindrical shape with an open proximal end portion 140 having a first diameter. The tip 142 terminates at a proximal flange wall 148 that is tapered down to the diameter of the neck 134, which is smaller than the first diameter of the proximal 140. The proximal flange wall 148 can be formed at an angle to the central longitudinal axis.

In some embodiments, the proximal portion 130 is circular or disc shaped. In some embodiments, the tip portion 132 is molded as a flange. In a further example, the tip 132 can be molded as a cylinder with a proximal 144, a tip 146 and an outer wall extending between them. The tip portion 132 includes a tip flange wall 150. The tip flange wall 150 is arranged at the base end portion 144 of the tip end portion 132. The tip flange wall 150 is oriented so as to intersect the central longitudinal axis of the anchor 110. When placed inside the patient in an extended configuration, the tip portion 132 can be placed within the duodenum. The tip portion 132 can define an opening at the tip portion 146 facing inward of the intestine 18.

The neck portion 134 includes a first end 160, a second end 162, and a wall extending between the first end 160 and the second end 162. The neck portion 134 can be formed as a cylinder extending between the base end portion 130 and the tip end portion 132. The neck portion 134 defines a penetrating lumen 152 that allows chyme to flow from the stomach 16 to the intestine 18. The neck portion 134 can be rigid to keep the pylorus 20 open, or the neck portion 134 can also be flexible to allow the penetrating lumen 152 to open and close with the pylorus 20. As used herein, the term "open" refers to a configuration that extends radially. That is, the base end portion 130, the neck portion 134 and / or the tip end portion 132 can be expanded and opened when the width 32 becomes wider.

The proximal flange wall 148 and the distal flange wall 150 can be tilted relative to the neck portion 134 to form a particular spatial relationship with the pylorus 20 at a particular location. In some embodiments, both the proximal portion 130 and the distal portion 132 are shaped to apply force F to the proximal and distal surfaces of the pylorus 20, respectively. The action of this force can help hold the implant in place and secure it on either side of the pylorus 20. The anchor 110 may be formed from a braided wire structure. The braided wire structure can contribute to placing the anchor 110 in the proper position inside the patient. For example, the braided wire structure helps to structurally support the anchor 110 and maintain the shape of the anchor 110.

As shown in FIG. 3, in some embodiments, the outer diameter of the tip portion 132 can define a gap or space between the tip portion 132 and the duodenum. In some embodiments, the gap or space between the outer diameter of the tip 132 and the duodenum is approximately perpendicular to the longitudinal axis at which the anchor 110 is defined by the central longitudinal axis of the anchor 110 or the opening of the pylorus. Allows you to rotate or turn in any direction. If the anchor 110 can rotate after being implanted in the patient, the tip portion 132 or anchor 110 may move or flex unnecessarily as a whole and may even disengage. Rotation or swivel of the anchor 110 or tip 132 can be prevented by making the tip 132 of appropriate length and diameter. Proper length of the tip 132 allows the tip 132 to come into contact with the duodenum and prevent further rotation before the tip 132 or anchor 110 flexes or disengages. can. The length of the tip portion 132 can determine the degree of rotation that the anchor 110 may receive before it comes into contact with the duodenum.

The length and diameter of the tip portion 132 can be sized to prevent tilting or tilting within a tubular anatomy such as the duodenum. In some embodiments, the length and diameter of the tip portion 132 is such that when the anchor 110 rotates or tilts away from the longitudinal axis, the tip portion 146 of the tip portion 132 contacts the intestinal wall and thus the patient. It is sized to prevent the movement of the anchor 110 inside the. The length of a suitable tip portion 132 capable of preventing unnecessary rotation, tilting or longitudinal deflection can be from about 10.0 mm to about 50.0 mm or any length in between. In some embodiments, the tip portion 132 can have a length sized to correspond to the width of the tip portion 132. In some embodiments, the tip portion 132 can have a length sized to correspond to the length of the proximal portion 130. For example, the length of the distal end portion 132 can be the same as the length of the proximal end portion 130. In some embodiments, the length of the distal end portion 132 can be a multiple of the length of the proximal end portion 130. For example, the tip portion 132 can be 1.5 times, 2 times, 3 times, or longer than the base end portion 130.

In some embodiments, the diameter of the tip portion 132 is about 5.00 mm to about 60.0 mm or any range in between, such as about 20.0 mm to about 50.0 mm or about 30.0 mm to about 40.0 mm. Can be. For example, the tip portion 132 is of about 18.0 mm to ensure that the structure can remain placed within a tubular anatomy such as the duodenal bulb having a diameter of about 40.0 mm. It can have a length and a diameter of 35.0 mm. The anchor 110 was formed with the diameter of the tip portion 132 having a diameter of about 35.0 mm.

In some embodiments, the diameter of the proximal portion 130 is from about 10.0 mm to about 75.0 mm or any range in between, such as about 25.0 mm to about 60.0 mm and about 40.0 mm to about 55. It is 0 mm. In one example, the anchor 110 was formed with a base end portion 130 having a diameter of about 40.0 mm.

In some embodiments, the diameter of the neck portion 134 is about 2.0 mm to about 30.0 m or any range in between, such as about 5.0 mm to about 30.0 mm and about 10.0 mm to about 20.0 mm. Can be. In one example, the anchor 110 was formed with a neck portion 134 having a diameter of about 15.0 mm.

In some embodiments, the length of the neck 134 may be approximately the width of the patient's pylorus. In some embodiments, the length of the neck portion 134 is greater than the width of the patient's pylorus to form a gap between the proximal flange wall 148, the distal flange wall 150, and the pylorus 20. Can be done. In some embodiments, the neck portion 134 may be sized so that the proximal flange wall 148 and the distal flange wall 150 can contact the pylorus 20.

The overall length of the anchor 110 can be from about 10.0 mm to about 100.0 mm, but anchors of various sizes can be formed depending on the patient's anatomy or anatomical suitability. In some embodiments, the length of the anchor 110 is from about 10.0 mm to about 100 mm, from about 25.0 mm to about 75.0 mm, from about 40.0 mm to about 60.0 mm, or any length within these ranges. It can be. In some examples, the anchor 110 can be about 45.0 mm to 55.0 mm in length. In one example, the formed anchor 110 was about 50.0 mm long. In some embodiments, the anchor 110 is compressible in diameter and the total diameter is, for example, from about 5.00 mm to about 10.0 mm in diameter to allow the anchor 110 to be attached to the catheter. Can be shortened to.

FIG. 4 is a perspective view of the anchor 110. In some embodiments, the anchor 110 may be self-expanding. In some embodiments, the anchor 110 comprises a structural element housed within a braided wire structure. As shown in FIG. 4, in some embodiments, the anchor 110 has a tip structural element 196. The tip structural element 196 can consist of rings 193, 194 attached to the tip portion 132 and / or the neck portion 134. The advanced structural element 196 is a nickel-cobalt alloy such as Nitinol (nickel-titanium alloy), one sold under the trade name MP35N (registered trademark), a cobalt alloy such as Alloy L605, and the trade name Elgiroy. Sold from metals such as cobalt-chromium-nickel-molybdenum alloys, stainless steels, such as those sold under (Elguiloy)®, or under PET, PEEK, trade name Delrin®. It can be made from plastics such as polyoxymethylene or any other suitable material. The tip structural element 196 can be made from a superelastic Nitinol wire formed into a suitable shape. In an exemplary embodiment, the tip structural element 196 was formed from three rings made of nitinol wire. If a tip structural element 196 with a particular rigidity or stiffness is desired, the size and the material from which the tip structure element 196 is made can be used to adjust these properties. For example, a nitinol wire can be used to form the reinforcing element with appropriate compression and expansion strength depending on the wire diameter used to make the tip structural element 196.

The tip structural element 196 is in the range of about 0.254 mm (0.010 inch) to about 1.016 mm (0.040 inch) or any range between this range, eg, about 0.381 mm (0.015 inch). It can be formed of a material having a thickness ranging from about 0.762 mm (0.030 inch), about 0.508 mm (0.020) inch to about 0.635 mm (0.025 inch). In an exemplary embodiment, the advanced structural element 196, consisting of a plurality of rings, was formed from a material having a thickness of about 0.020 inches, i.e. about 0.51 mm. Typically, each ring 193, 194 capable of forming the tip structural element 196 is from about 25.4 mm (1.0 inch) to about 50.8 mm (2.0 inch) and any range within this range, such as about 30. It has the same diameter in the range of 48 mm (1.2 inches) to about 45.72 mm (1.8 inches) and about 33.02 mm (1.3 inches) to about 43.18 mm (1.7 inches). In an exemplary embodiment, the advanced structural element 196 contained materials formed in rings 193, 194, each ring having a diameter of approximately 1.38 inches, i.e. 35.0 mm.

As shown in FIG. 4, the rings 193 and 194 of the tip structural element 196 are arranged on the four sides of the tip portion 132, and are attached to the tip portion 132 by being integrally woven into the flange material. The rings 193, 194 of the tip structural element 196 can be assembled by first assembling the rings 193, 194 through the braided structure of the tip portion 132, then inserting the wire ends into the connecting sleeve and crimping or welding.

As shown in FIG. 4, in some embodiments, the anchor 110 can have a proximal structural element 172 attached to the proximal portion 130. The proximal structural element 172 can be a compression urging element such as a spring. The proximal structural element 172 can be constructed as a substantially circular frame with protrusions 186. The proximal structural element 172 can be constructed from the same material that forms the distal structural element 196. The proximal structural element 172 can also structurally support the proximal portion 130. For example, the proximal structural element 172 usually has an overall frame that is compressible and also rigid. The proximal structural element 172 can impart additional radial strength to the proximal portion 130 and contribute to keeping the proximal portion 140 of the proximal portion 130 open. The proximal structural element 172 can be shaped to deviate the collapse direction of the anchor 110 for removal from the patient and for mounting the device on a delivery catheter for delivery inside the patient.

As shown in FIG. 4, in some embodiments, the anchor 110 may include a drawstring 192. The drawstring 192 is attached to the proximal portion 130. The drawstring 192 can be attached to the proximal portion 130 by passing the drawstring 192 through the material of the proximal portion 130 and assembling it. As shown in FIG. 5, the drawstring can be assembled through the material of the proximal portion to form a loop 198 on a portion of the drawstring. For example, the drawstring 192 can be constructed from a cord or sewing thread, and the string or sewing thread is assembled by passing it through every other cell of the braided wire structure of the anchor 110. The loop 198 allows the drawstring 192 to be attached to a pull-back tool, such as a hook or clamp. In some embodiments, the drawstring 192 is a sewing thread that is assembled through the proximal end portion 130. The drawstring 192 may have a different structure than the proximal structural element 172. The drawstring 192 can be constructed from sewing material and can include thin wires or cables.

FIG. 5 shows a base end portion 130 of an anchor 110 having a collapsed configuration. The drawstring 192 can be used to elastically shrink the anchor 110 by connecting at least one loop 198 to a take-out device and pulling it into a sheath. In some embodiments, the drawstring 192 allows the proximal portion 130 to collapse to the diameter of the neck portion 134. The drawstring 192 can also be attached to various parts of the anchor 110, such as in the neck portion 134 or the tip portion 132. The anchor 110 may also have a plurality of drawstrings to sequentially crush various parts of the anchor 110 during embedding or removal.

FIG. 5 shows a base end portion 130 of a crushed configuration, such as after the drawstring 192 has been pulled. In some embodiments, the anchor 110 may be configured to be appropriately collapsed to a smaller size. For example, the anchor 110 can be crushed to a smaller diameter for placement inside the patient or removal from the patient. In some embodiments, the anchor 110 can be crushed by pulling the drawstring 192, for example by pulling the loop 198. The loop 198 of the drawstring 192 can be pulled away from the anchor 110 to crush the proximal structural element 172.

FIG. 6 is a perspective view of the gastrointestinal device 100 in which the sleeve 120 is attached to the anchor 110. FIG. 7 is a perspective view of the gastrointestinal device 100 in which the sleeve 120 is attached to the anchor 110, showing further features. As shown in FIG. 7, the overall schematic of the sleeve 120 includes a mouth 180, a sleeve body 182 and a neck 184. The diameter of the sleeve body 182 is usually sized to correspond to the diameter of the human intestine. The diameter of the sleeve 120 is reduced at the neck 184 to match the inner diameter of the anchor 110. This change in diameter also contributes to the sleeve 120 preventing the sleeve from turning over and overlapping itself in response to the increased pressure exerted on the outside of the sleeve 120. According to various embodiments, the sleeve body 182 has a wall thickness of about 0.0254 mm (0.001 inch) to about 0.381 mm (0.015 inch). The neck 184 of the sleeve 120 can be thicker than the sleeve body 182, for example, the neck 184 is from about 0.0254 mm (0.001 inch) to form a second mechanism to prevent the sleeve from turning over. It can have a wall thickness of about 0.127 mm (0.005 inch) thick. When the sleeve 120 receives external pressure, the thicker neck 184 collapses, preventing the sleeve 120 from folding back and overlapping itself. This mechanism can effectively form a Duckbill valve.

The sleeve 120 can have a length of about 25.4 mm (1.0 inch) to about 50.8 mm (about 2.0 inch), up to a few feet in length. In some embodiments, the sleeve 120 is sized to extend beyond the length of the duodenum to the Tritz ligament when unfolded. On the other hand, various embodiments disclosed herein are described as entering the duodenum with respect to the sleeve 120. In general, the sleeve 120 is also intended to have sufficient length, partially or completely, to allow the sleeve 120 to enter the jejunum. The appropriate length of the sleeve 120 can be defined by the required mechanism of action. In some examples, the effective sleeve length is the length that allows the sleeve to reach the proximal jejunum. This position coincides with the position of the Treitz ligament. The length of the sleeve is determined based on the desired clinical outcome. In some examples, a sleeve approximately 0.6 m (2 ft) long is sufficient to correct the transfer and absorption of food and organ secretions in the intestine and ameliorate type 2 diabetes.

The sleeve 120 can be made from thin polymer materials such as silicone, polyurethane, polytetrafluoroethylene, fluorinated ethylene propylene, polyethylene, stretched polytetrafluoroethylene (ePTFE) or other suitable materials. In an exemplary embodiment, the wall thickness of the sleeve 120 can be from about 0.015 mm (0.0006 inches) to about 0.254 mm (0.010 inches). The sleeve 120 can be made by extrusion in a tubular form or inflatable tube, dip-coated from a liquid solution, powder-coated from polymer fine particles, or paste-extruded, and then with ePTFE. It can be stretched in the same way.

In some embodiments, the gastrointestinal device 100 can be endoscopically implanted in the pylorus 20 or endoscopically removed from the pylorus 20 with the anchor 110 in a collapsed or compressed configuration. As used herein, a closed, compressed, or collapsed configuration is an anchor in which at least one diameter of the proximal portion 130 or the distal portion 132 is reduced in the direction of the width 32 (shown in FIG. 3) of the anchor 110. Point to 110. After embedding, the anchor 110 is released and can take an open or expanded configuration. In an open or expanded configuration, the anchor 110 usually anchors itself to maintain at least a portion of the gastrointestinal device 100 within the pylorus 20.

FIG. 8 is a perspective view of an overall schematic view of the take-out device 200. In some embodiments, the withdrawal device 200 can be used as a withdrawal device for removing foreign objects such as anchors, stents or medical devices from the patient's body. The ejector 200 can be used to remove the expandable anchor 110 and sleeve 120 from the patient's body. As used herein, the extraction device 200 is described in connection with removing or withdrawing a gastrointestinal device 100, such as the gastrointestinal device 100 already disclosed in FIGS. 1-7, from the patient's stomach or intestine. However, it is also envisioned that other foreign bodies may be removed or withdrawn from within the patient using the systems and methods described herein. For example, the unloading device 200 can modify or add specific components to allow foreign objects of various shapes and materials to be captured and withdrawn from inside the patient.

As shown in FIG. 8, the extraction device 200 includes a hook assembly 210 and a capsule assembly 212. As shown, the capsule assembly 212 includes a capsule 230, a capsule shaft 232 and a handle 234. In some embodiments, the hook assembly 210 includes a hook cable 220 and a hook sheath 222. In some embodiments, the hook assembly 210 includes a hook cable 220 without a hook sheath 222. In some embodiments, when in use, the hook cable 220 is received within the hook sheath 222 to form the hook assembly 210. In the unfolding method, the first portion of the ejector 200, such as a portion of the hook assembly 210 and the capsule assembly 212, can be configured to be inserted into the patient's body and the second portion of the ejector 200, such as the handle 234. Part stays outside the patient.

9A and 9B are side views of a schematic diagram of the hook assembly 210 that can be used in the unloading device 200 of FIG. In some examples, the hook assembly 210 includes a hook cable 220 and a hook sheath 222. In a further example, the hook assembly 210 can include a hook cable 220 without a hook sheath 222. In some examples, the hook cable 220 and hook sheath 222 can be formed as a single integration. For example, the hook cable 220 and the hook sheath 222 are combined into a single integrated form to form the hook assembly 210. In a further example, the hook cable 220 and the hook sheath 222 can be formed as two separate devices that are combined to form the hook assembly 210. As shown in FIGS. 9A and 9B, the hook assembly 210 has a hook cable 220 and a hook sheath 222. In some embodiments, the hook assembly 210 fits within the working channel of a standard endoscope. In some embodiments, the hook assembly 210 has an inner diameter of about 1.4 mm, about 1.6 mm, about 1.8 mm or about 2.2 mm, about 2.4 mm or about 2.6 mm, or any of the aforementioned values. It fits within the working channel of a standard endoscope, which is paired with each other, but with additional dimensions. For example, the hook assembly 210 can be sized appropriately to be inserted into the working channel of an endoscope with an inner diameter of about 2.8 mm. In one example, the assembly 210 was formed to fit into an endoscopic channel with an inner diameter of 2.0 mm.

As shown in FIG. 9A, the hook cable 220 has a first end 310, a second end 312, and a length portion in between, and defines a longitudinal axis 314. In the example of the hook assembly 210 having the hook cable 220 without the hook sheath 222, the first end 310 of the hook cable 220 can define the first end of the hook assembly 210. The first end 310 of the hook cable 220 is a gripping mechanism, hook, fastener, arm, basket or fingers that attaches to or grips an object such as a medical device or foreign body. Includes mounting feature portion 340. In some embodiments, the mounting feature 340 defines a first end 310 of the hook cable 220. The mounting feature portion 340 can have a length portion 344 and a width portion 346 sized and shaped to correspond to a particular suitable dimension. For example, the mounting feature portion 340 may have a length portion 344 suitable for attaching to a drawstring such as the drawstring 192 already described in FIGS. 4 and 5 and holding the drawstring. The width portion 346 may be sized to allow the mounting feature portion 340 to fit in the hook sheath 222. That is, the width portion 346 may be sized to allow the entire mounting feature portion 340 to fit within the first inner diameter 326 and the second inner diameter 370 of the hook sheath 222. The mounting feature 340 can be used to capture and / or lock the drawstring and pull the drawstring into the hook sheath 222.

As shown in FIG. 9A, the hook assembly 210 includes a hook cable stopper 360 disposed along the hook cable 220. In some embodiments, the hook cable stopper 360 can define an outer diameter 362 that is larger than the first inner diameter 326 of the hook sheath 222. In some embodiments, the hook cable stopper 360 can have an outer diameter 362 such that it is prevented from entering the hook sheath 222.

As shown in FIG. 9A, in some embodiments, the length of the hook cable 220 is longer than the length of the hook sheath 222. The hook cable 220 is sized to be accommodated within the hook sheath 222. In some embodiments, the hook cable 220 can be inserted into the hook sheath 222 by inserting the first end 310 having the mounting feature 340 into the second end of the hook sheath 222. The hook cable 220 can advance along the inside of the hook sheath 222 until the first end 310 of the hook cable 220, such as the mounting feature 340, protrudes from the first end 320 of the hook sheath 222. ..

As shown in FIG. 9B, the hook sheath 222 has a first end 320, a second end 322, and a length portion between them along the longitudinal axis of the hook sheath 222. The hook sheath 222 can include a flexible tube having an inner surface 378 and an outer surface 376 that define the lumen. The hook sheath 222 has a first inner diameter 326 and a first outer diameter 328 at the first end 320. The hook sheath 222 can have a second inner diameter 370 and a second outer diameter 372 at the second end 322. In some embodiments, the second inner diameter 370 and the second outer diameter 372 can be the same as the first inner diameter 326 and the first outer diameter 328, respectively. In some embodiments, the first inner diameter 326 of the hook sheath 222 is sized to accommodate the mounting feature 340 or other pull-back tool within the first inner diameter 326. For example, the first inner diameter 326 and the second inner diameter 370 of the hook sheath 222 may be sized so that the mounting feature 340 can be inserted into the hook sheath 222.

In some embodiments, the hook sheath 222 is constructed as a flexible tube that can bend or bend at an angle to the longitudinal axis 324. The hook sheath 222 may be flexible in the direction perpendicular to the longitudinal axis 324 and further incompressible in the longitudinal direction along the longitudinal axis 324. For example, the hook sheath 222 can be constructed as a close contact coil made of an elastic material such as metal or plastic. The coil can bend or bend in a direction perpendicular to the length of the coil, such as along the longitudinal axis 324. The tight coil can prevent the coil from compressing in the direction of the longitudinal axis 324, and the coil is elastic to prevent the hook sheath 222 from extending or stretching along the longitudinal axis 324 of the hook sheath 222. Can be. That is, the hook sheath 222 may have minimal compressibility to be maintained at a set length due to the hook sheath material structure.

The hook sheath 222 can cover the inner surface 378 and / or the outer surface 376. For example, if the hook sheath 222 is constructed as a coil, the coating may cover or fill the space between the windings of the coil to provide a smooth and uniform surface along the inner and outer surfaces 378 and 376 of the hook sheath 222. can. In some embodiments, the hook sheath 222 can have a coating that can form a smooth, uniform surface and prevent the coil from opening up space. The coating material can be selected to reduce friction along the inner and outer surfaces 378 and outer surface 376 of the hook sheath 222. For example, the outer surface 376 of the hook sheath 222 may be provided with a coating suitable for reducing friction with the patient's tissue, such as esophageal tissue or gastric tissue. The inner surface 378 of the hook sheath 222 may be provided with a coating suitable for reducing friction with a further feature portion of the take-out device 200 that can be inserted into the hook sheath 222, such as a hook cable 220. In some embodiments, the coating of the hook sheath is a smooth plastic or polymer such as polytetrafluoroethylene, such as that sold under the trade name Tetrafluoroethylene (FEP) or Teflon Fluorinated (FEP). Coating may be included. In some embodiments, the coating of the hook sheath can be formed from a meltable and reflowable material such as a thermoplastic or a thermoplastic elastomer. For example, the coating of the hook sheath can be formed from a polyether block resin such as that sold under the trade name Pebax®.

As shown in FIG. 9A, the hook assembly 210 also includes a hook cable lock 350 arranged along the hook cable 220. In some embodiments, such as the example of a hook assembly 210 having a hook cable 220 without a hook sheath 222, the hook assembly 210 can be formed without the hook cable lock 350. In the example of the hook assembly 210 including the hook cable 220 and the hook sheath 222, the hook cable 220 and the hook sheath 222 can be formed as two separate devices to be combined. For example, the hook cable lock 350 can be configured to lock the hook cable 220 longitudinally with respect to the hook sheath 222. The hook cable lock 350 may include a restraining mechanism that prevents the hook cable 220 from moving relative to the hook sheath 222 along the longitudinal axis 324 of the hook sheath 222. As an example, the hook cable lock 350 may include a thread that can engage the corresponding thread on the hook sheath 222. In a further example, the hook cable lock 350 may include a tab or finger (not shown) within the inner diameter of the hook sheath 222, where the tab or finger is when a portion of the lock sheath 354 is inserted. Transforms into. The finger body can be configured to hold both the hook sheath 222 and the lock sheath 354 in the first configuration, disabling the lock and releasing the hook sheath 222 and the lock sheath 354 from each other. It can have built-in features that make it possible. In another example, the hook cable lock 350 may include a holding mechanism such as a collet, chuck or tab that applies compressive force to the hook cable 220 to prevent movement of the hook cable 220.

9A and 9B show exemplary embodiments of the hook cable lock 350, which can be configured to lock both the hook cable 220 and the hook sheath 222 to form the hook assembly 210. As shown, the cable 220 can include a plurality of wires 352 arranged along the length portion of the hook cable 220. The plurality of wires 352 are bundled near the second end 312 of the hook cable 220. The hook cable lock 350 can have an outer diameter 362 larger than the first inner diameter 326 of the hook sheath 222. In some embodiments, the hook cable lock 350 has an outer portion 356 and may include a lock sheath 354 that surrounds the outer perimeter of the plurality of wires 352 and extends and locks between the two or more wires 352. It has a pointed rod 358 attached to the outer portion of the sheath 354. The outer portion 356 of the lock sheath 354 can have, for example, an inner diameter larger than the outer circumference of the plurality of wires 352, with or without the pointed rod 358 inserted between the two or more wires 352. The cusps 358 of the lock sheath 354 have an appropriate width so that when the cusps are placed between two or more wires 352, the two or more wires 352 are separated from each other by a specific distance. be able to. When the pointed rod 358 is arranged between two or more wires 352, the plurality of wires 352 have an overall outer circumference larger than the inner diameter of the lock sheath 354. When the spigot 358 of the lock sheath 354 is inserted between the plurality of wires 352, the plurality of wires 352 are separated from each other by a predetermined distance, so that the plurality of wires 352 are at least the tip rods of the hook cable 220. Along the portion adjacent to 358, the hook sheath 222 will have an overall outer diameter 362 larger than the second inner diameter 370. The lock sheath 354 can move along the hook cable 220 towards the second end 322 of the hook sheath 222. When the lock sheath approaches the second end 322 of the hook sheath 222, the pointed rod 358 separates the plurality of wires 352 and makes the overall diameter larger than the second inner diameter 370 of the hook sheath 222. This prevents the hook cable 220 from further moving into the hook sheath 222.

As shown in FIG. 9B, the lock sheath 354 can be arranged along the length portion of the hook cable 220 excluding the hook sheath 222. The length portion of the hook cable 220 includes two wires, and the hook cable lock 350 can be advanced or retracted along the length portion of the hook cable 220 excluding the hook sheath 222. The pointed rod 358 of the hook cable lock 350 lies between the two wires, and the outer portion 356 surrounds the two wires. When the pointed rod 358 of the hook cable lock 350 is between the two wires, the hook cable 220 is extended so that the outer diameter of the hook cable 220 is larger than the second inner diameter 370 of the hook sheath 222. This configuration prevents the hook cable 220 from moving longitudinally from the hook sheath 222 into the second end 322. According to some embodiments, the features of the locking mechanism for locking the hook cable may be of the type described in European Patent No. 1832250, which is described herein by reference. Incorporated in.

In some embodiments, the hook cable 220 can be made from a material that has adequate tensile strength and is also biocompatible. For example, the hook cable 220 may be made of a metal or metal alloy such as stainless steel, Nitinol, MP3 5N (nickel-cobalt-chromium-molybdenum alloy) formed on a single cable or as a stranded wire. Can be done. In some embodiments, the hook cable 220 may include a composite material, polymer or plastic to impart additional material properties. The hook cable 220 can have an outer diameter ranging from a width of about 0.508 mm (0.020 inch) to a width consistent with the inner diameter of the hook sheath. In an exemplary embodiment, a hook cable with a diameter of 0.635 mm (0.025 inch) was made.

In some embodiments, the lock sheath 354 and / or the hook cable stopper 360 is longitudinally incompressible and further flexible, such as laterally, at an angle to the longitudinal axis. It can be made from suitable materials. In some embodiments, the lock sheath 354 and / or the hook cable stopper 360 can be made from a material that is rigid and can be molded to fit within the hook sheath 222. In some embodiments, the lock sheath 354 and / or the hook cable stopper 360 can be made from the same material as the hook cable 220. The lock sheath 354 and / or the hook cable stopper 360 can be made of steel. The lock sheath 354 and / or the hook cable stopper 360 can include a coating such as a plastic coating or a polymer coating. In some embodiments, the lock sheath 354 and / or the hook cable stopper 360 can be color coded for ease of use.

9C shows a side view of the hook 341 that can be used in the hook assembly 210 shown in FIGS. 9A and 9B. As shown, the hook 341 includes a shank 342 and an endpoint 343. The hook 341 can include a gap 345 formed between them by a shank 342 and an endpoint 343. The hook 341 can be shaped so that the object can be placed within the gap 345. The hook 341 can include a bend 349 along a portion of the shank 342. The shank 342 and the endpoint 343 can be configured such that an object disposed within the gap 345 is held by the hook 341. For example, the endpoint 343 can be located near the shank 342 and can come into contact with the shank 342. When the hook 341 unfolds, the endpoint 343 can be used to hold the object within the gap 345, and the endpoint 343 and the shank 342 can be shaped to prevent the object from being released from the hook 341. can. The shank 342, the endpoint 343 and the gap 345 can define the contour 347 of the hook 341. In some examples, the contour 347 of the hook 341 may be sized so that the hook 341 can be inserted into the lumen of the endoscope. In a further example, the contour 347 of the hook 341 can have a size and / or shape suitable for being inserted into the hook sheath 222 shown in FIGS. 9A and 9B. The hook 341 is about 1.0 mm, about 1.4 mm or about 1.8 mm to about 2.2 mm, about 2.6 mm or about 3.0 mm wide, or any pair of widths of the above values. , Further dimensions are also possible contours 347 can be defined.

FIG. 10 shows a side view of the capsule assembly 212. As shown in FIG. 10, the capsule assembly 212 includes a capsule 230, a capsule shaft 232 and a handle 234. The capsule 230, capsule shaft 232 and handle 234 are attached to each other to form the capsule assembly 212. The handle 234 has a first end 420 and a second end 421. The capsule shaft 232 has a first end 414, a second end 416, and a length portion 418 in between. In some embodiments, the capsule 230 has a first end 410 and a second end 412. The first end 410 defines an inward opening 409 of the capsule 230. The first end 414 of the capsule shaft 232 is attached to the second end 412 of the capsule 230. The first end 420 of the handle 234 is attached to the second end 416 of the capsule shaft 232.

The capsule 230, capsule shaft 232 and handle 234 can each have an outer diameter. The capsule 230, the capsule shaft 232 and the handle 234 can each have an inner peripheral hole defining an inner diameter. After assembly, the capsule 230, capsule shaft 232 and handle 234 are in series with the inner holes of each capsule 230, capsule shaft 232 and handle 234 so that the capsule assembly 212 forms a continuous inner hole along the length of the capsule assembly 212. Can be assembled adjacent to.

In some embodiments, the handle 234 has a first control knob 436 located at the first end 420, a second control knob 438 located at the second end 421, and a central core 440. And have. In some embodiments, the handle 234 includes a third sheath 444 that is nested within a second sheath 442, and the second sheath 442 is nested within a central core 440. The central core 440 forms the outer sheath of the handle 234. In some embodiments, the handle 234 may include a hook assembly lock 580. In some embodiments, the handle 234 can be a pull-out mechanism, a recovery mechanism or a tension mechanism. In some embodiments, the handle 234 can have a contracted or compressed configuration and an stretched or stretched configuration.

As shown in FIG. 10, the capsule shaft 232 is usually molded as an elongated tube having an inner diameter of 426 and an outer diameter of 424. In some embodiments, the inner diameter 426 and outer diameter 424 of the capsule shaft 232 vary at specific points along the length portion 418 of the capsule shaft 232. The outer diameter 424 and / or inner diameter 426 of the capsule shaft 232 at the first end 414 can be the same size as the inner diameter 404 and outer diameter 422 of the capsule 230 at the second end 412. In some embodiments, the capsule shaft 232 is constructed as a flexible tube that can bend or bend at an angle with respect to the longitudinal axis of the capsule shaft 232 or relative to the longitudinal axis of the capsule shaft 232. Will be done. The capsule shaft 232 may be longitudinally incompressible along the length 418 of the capsule shaft 232. For example, the capsule shaft 232 can be constructed as a close contact coil made of an elastic material such as metal or plastic. The coil can bend or bend in a direction perpendicular to the length of the coil. The close-fitting coil can prevent longitudinal compression, and the coil can be elastic to prevent the capsule shaft 232 from stretching or stretching along length 418. That is, the length 418 of the capsule shaft 232 is maintained at the set length by the structure of the capsule shaft 232.

The capsule shaft 232 can cover the inner surface 429 and / or the outer surface 430. In some examples, if the capsule shaft has space along the inner surface 429 and / or the outer surface 430, such as when the capsule shaft 232 is constructed as a coil, the coating covers or fills the space between the coil windings. A smooth and uniform surface can be provided along the inner surface 429 and / or the outer surface 430 of the capsule shaft 232. The coating can be selected to reduce friction with other objects along the inner surface 429 and outer surface 430 of the capsule shaft 232. For example, the outer surface 430 of the capsule shaft 232 may be provided with a coating suitable for reducing friction with the patient's tissue, such as esophageal tissue or gastric tissue. The inner surface 429 of the capsule shaft 232 may be provided with a coating suitable for reducing friction with an object that can be inserted into the capsule shaft 232, for example, a further feature of the extraction device 200 such as the hook sheath 222 described above. .. The coating may include a smooth plastic or polymer coating. For example, the coating can be formed from any suitable material that results in a smooth surface with a low coefficient of friction. The coating can be formed from a medical material with a low coefficient of friction. For example, the coating may include a smooth plastic or polymer coating such as polytetrafluoroethylene, such as that sold under the fluorinated ethylene propylene (FEP) or the trade name Teflon ™. The coating can include meltable and reflowable materials such as thermoplastics or thermoplastic elastomers. For example, the coating can be formed from a polyether block resin, such as that sold under the trade name Pebax®.

As shown in FIG. 10, the capsule 230 is substantially cylindrical in shape and has a first end 410, a second end 412, a first portion 406 and a second portion 408. As shown, the capsule 230 has an outer diameter 402 along the first portion 406, an outer diameter 422 along the second portion 408, and an inner peripheral hole defining an inner diameter 404. The capsule 230 can be shaped to facilitate insertion of the capsule 230 into the patient's body, such as a body cavity. In some examples, the first end 410 of the capsule 230 can be rounded or tapered and the second end 412 can be rounded or tapered. That is, the inner and / or outer diameters of the capsule 230 are, for example, the outer diameter portion 422 and the outer diameter portion 422 and to define an appropriate shape that contributes to inserting the capsule 230 inside the patient or withdrawing the capsule 230 from the patient. The size can be changed at various positions along the inner diameter portion 404. The outer diameter 402 along the first portion 406 of the capsule can be substantially constant along the length of the capsule 230, and the outer diameter 422 along the second portion 408 is the second end 412. The size changes, such as tapering near. In some embodiments, the second portion 408 of the capsule 230 tapers or shrinks from the outer diameter 402 of the first portion 406 to a size substantially identical to the outer diameter 424 of the capsule shaft 232. Can have an outer diameter of 422.

The first portion 406 of the capsule 230 can have a relatively constant inner diameter 404 along the length inside the capsule 230. In some embodiments, the inner diameter of the second portion 408 is tapered internally near the second end 412 of the capsule 230. In some embodiments, the second portion 408 has a tapered inner diameter that is reduced from the inner diameter 404 of the first portion 406 to an inner diameter that is substantially the same as the inner diameter 426 of the capsule shaft 232.

In some embodiments, the capsule 230 can be formed from a single unit. That is, the capsule can be formed as a continuous piece of material that forms the entire capsule 230. In another example, the capsule 230 can be formed from a plurality of components forming the capsule 230. Various additional features can be obtained by forming the capsule 230 from a plurality of components. This will be further described below with reference to FIGS. 11-14.

In some embodiments, the capsule 230 can be constructed from a rigid and durable material such as metal, plastic or other polymer. For example, the capsule 230 can be made from any suitable medical material that provides a low friction and smooth surface. In some embodiments, the capsule 230 can be formed from fluorinated ethylene propylene (FEP), polyoxymethylene (POM), polycarbonate, PEEK or nylon. In some embodiments, the capsule 230 can be constructed from a flexible material that can bend or deform around an object and is substantially rigid and incompressible along the capsule length. can. For example, the capsule 230 may be flexible to facilitate the advancement of the capsule into the patient's body. The capsule 230 can be bent at an angle with respect to the longitudinal axis of the capsule 230. In some embodiments, the capsule 230 can be formed in a tube or lumen. In some embodiments, the capsule 230 can be made from a coil reinforcing tube or a spring or a tube cut to form a coil. Capsules 230 can incorporate segments along the length of the capsule, each segment containing a space between the segments. The space allows the capsule to bend or bend laterally and then collapse due to compressive forces acting along the length of the capsule to form a rigid structure.

The capsule 230 can have a liner or coating that covers a portion of the surface of the capsule 230 along the inner diameters 404 and 428 and / or a coating that covers a portion of the surface of the capsule 230 along the outer diameters 402 and 422. The liner or coating can be a low-friction or low-friction liner. A low-friction or low-friction liner allows the capsule 230 to be inserted into the patient's body or the object to be pulled into the capsule 230 with less force. For example, a coating made of polytetrafluoroethylene, such as that sold under the FEP or trade name Teflon ™, is applied to the surfaces of inner diameters 404, 428 and / or outer diameters 402, 422 of the capsule 230. Can be added. In some embodiments, the capsule 230 may include a material that allows the capsule 230 to be viewed using radiographs while inside the patient.

11A and 11B show perspective views and side views of further examples of the capsule 230 according to the various aspects of the present disclosure, respectively. As shown in FIGS. 11A and 11B, the capsule 230 includes a first portion 406, a second portion 408, and a third portion 407 located near the first end 410. As shown in FIG. 11B, the third portion 407 defines an inward opening 409 of the capsule 230. The opening 409 is sized and shaped to allow the capsule 230 to accept an object, such as the anchor 110 shown in FIG. 6, into the capsule 230. In some embodiments, the third portion 407 has the same outer diameter 411 as the outer diameter 402 of the first portion 406. An alternative configuration of capsule 230 is also envisioned. For example, in some examples, the third portion 407 has an outer diameter 411 that is larger than the outer diameter 402 of the first portion 406. In some examples, the third portion 407 has the widest outer diameter near the first end 410 and the narrowest outer diameter near the first portion 406. The third portion 407 can also have an inner diameter that is widest at the portion of the first end 410 near the opening 409 and tapered to a smaller diameter near the first portion 406. The second portion 408 can have the widest outer diameter 422 at the portion closest to the first portion 406, and the outer diameter 422 is tapered to a smaller outer diameter near the second end 412. ing.

FIG. 11B includes a partially fractured view along a portion of the capsule 230 to show additional features. As shown, at least a portion of the capsule 230 comprises a coil 413 made of one material that rotates about a central longitudinal axis that roughly coincides with the axis indicated by arrow 405. In another example, the capsule can include a material formed in a braided or woven structure. In some embodiments, the coil 413 defines the body of the capsule 230. That is, the coil 413 extends from the first end 410 to the second end 412 and defines the overall length of the capsule 230. The coil 413 can have an increased or decreased radius of curvature along a portion of the length of the coil. The coil 413 can define, for example, an outer diameter tapered in the direction of the central longitudinal axis along the second portion 408 and / or the third portion 407. The coil 413 can define an inner surface that defines a lumen extending along the length of the first portion 406, the third portion 407 and / or the second portion 408. In some examples, the third portion 407 can be formed from the first end piece and the second portion 408 can be formed from the second end piece. This is further described below.

In some embodiments, the coil 413 can be stripped of coating and the coil 413 defines the outer and inner surfaces of the capsule 230. As shown in FIG. 11B, the capsule 230 can include a cover 415. The cover 415 can be a coating applied onto the coil 413. For example, the cover 415 can be a coating such as a polymer or resin that is applied onto the coil and can be formed or cured around the outer and / or inner surface of the coil 413. The cover 415 can be a film that is formed separately from the coil and then laminated or wound around the coil 413. In another example, the cover 415 can be extruded separately from the coil 413 and then applied to the surface of the coil, for example as a coating. The cover 415 can fill the space between each winding of the coil 413 to form a single body, with smooth continuous surfaces defining the outer and / or inner surfaces of the capsule 230.

In some examples, the cover 415 is made of a rigid material that keeps the capsule 230 in proper shape. In another example, the cover 415 can be formed from a flexible or flexible material so that the capsule 230 can bend or bend. For example, the cover 415 can be formed from a polymer such as plastic or rubber, which is added onto the coil 413 to keep the cover 415 as a continuous layer covering the coil 413 while the cover 415 is coiled. Allows you to bend with 413. The cover 415 can include a material that reduces friction with an object that can come into contact with the capsule 230. In some embodiments, the cover 415 can include a hydrophilic material. In some embodiments, the cover 415 is a polyoxymethylene or a trade name Pevacs, such as those sold in nylon, polycarbonate, polyethylene, polyethylene terephthalate, polyacetal, polyformaldehyde, trade name Delrin®. Polymers such as polyether block resin, such as those sold under (Pebax)®, can be included. The cover 415 has a coefficient of friction so that the capsule 230 can move forward in the patient's body cavity, such as the esophagus, stomach or intestine, or the object can be pulled into the capsule with minimal force. Can contain small materials. For example, cover 415 can include materials such as silicon, FEP or Teflon ™.

12A and 12B show end and side views of the coil 413, respectively, showing additional features. The coil 413 can be formed from a stranded material wound around a central longitudinal axis to form a cylinder. As shown in FIG. 12A, the coil 413 forms a cylinder with an inner surface 425 and an outer surface 427. The cylinder defined by the coil 413 defines the interior space that defines the lumen. As previously disclosed, in some examples, the inner and outer surfaces 425 and 427 of the coil 413 define the inner and outer surfaces of the capsule 230. That is, in some examples, the inner surface 425 and the outer surface 427 of the coil 413 are uncovered or uncovered with additional components. In some examples, the outer surface 427 and / or the inner surface 425 of the coil 413 can be covered with a second material. The second material can fill the space between adjacent windings of the coil to define an integral continuous surface inside the capsule 230. For example, the outer surface 427 and / or the inner surface 425 of the coil can be covered with a coating or liner made of a second material, or the second material is inserted into the coil 413 and into a tube forming the inner surface of the capsule 230. Can be formed. For example, a second material can be used to reduce friction and / or have wear resistance to ensure that the passage of the object drawn into the capsule 230 is smooth and continuous. The second material can be a hydrophilic material or a non-adherent material such as a PTFE liner. In a further example, the cover 415 shown in FIG. 11B can be attached to the outer surface 427 of the coil 413 to define the outer surface of the capsule 230. In addition or instead, the cover 415 can be attached to the inner surface 425 of the coil 413 to define the inner surface of the capsule 230 shown in FIGS. 11A and 11B. For example, a second material that may be included along the inner surface 425 of the coil 413 to form the inner surface of the capsule 230 is nylon, polycarbonate, polyethylene, polyethylene terephthalate, polyacetal, polyformaldehyde, trade name Delrin ( It can be a polymer such as polyoxymethylene such as that sold under the registered trademark) or a polyether block resin such as that sold under the trade name Pevax®. The inner surface 425 of the coil 413 can be lined with a second material that does not adhere or has a low coefficient of friction, such as silicon, FEP or Teflon ™.

As shown in FIG. 12B, the coil 413 can be formed from a stranded material wound around a central longitudinal axis to form a cylinder. In another example, the coil can be formed from a stranded material that is formed into additional patterns such as woven patterns, spiral patterns, braided patterns or other patterns. The windings of the coil can be in close contact and, in some examples, can contact each other, which prevents the coil 413 from being compressed along the central longitudinal axis. The coil 413 may be elastic to prevent the coil 413 from extending or stretching along the central longitudinal axis and allowing the gap to open between adjacent windings. The individual windings of the coil 413 can be adjacent to each other and in contact with each other, and also in a direction perpendicular to the central longitudinal axis so that the coil 413 can bend or bend in a direction perpendicular to the central longitudinal axis. Can move relative to each other. The coil 413 can also be elastic to prevent the coil 413 from being compressed or collapsed inward towards the axis of the coil 413. When the coil 413 resists compression and expansion along the central longitudinal axis, the individual windings of the coil separate, opening gaps between adjacent windings and without forming a pinch point when the gap closes. , Coil 413 can be inserted into or recovered from the body cavity.

The coil 413 is elastic, maintains a cylindrical shape defining a continuous outer surface 427 and / or inner surface 425, and is more flexible so that it can flex or bend along the central longitudinal axis. Can be configured. In some examples, the coil 413 is elastic enough to withstand expansion or compression due to forces along the length or circumference of the coil 413. For example, the coil 413 may be elastic to withstand compression or expansion in the direction of the central longitudinal axis as the object is pulled into the coil 413. The coil 413 can also be elastic to withstand expansion or compression along the circumference while the object is placed within the coil 413.

As shown in FIG. 12A, the coil 413 can have a wall thickness defined between the inner diameter portion 425 and the outer diameter portion 427. In some examples, the wall thickness is about 0.05 cm, about 0.10 cm, about 0.15 cm, about 0.2 cm or any pair of values described above, but additional thickness is also conceivable. In the example, a coil 413 with a wall thickness of about 0.14 cm was formed. The outer surface 427 of the coil 413 defines the outer diameter of the coil 413. In some examples, the outer diameter of the coil 413 is about 0.50 cm, about 1.0 cm, about 1.5 cm, about 2.0 cm or any pair of values described above, but also with additional thickness. Conceivable. In one example, a coil 413 with an outer diameter of about 1.4 cm was formed. In some examples, the length of the coil is about 5.0 cm, about 7.0 cm, about 11.0 cm, about 13.0 cm or any pair of values described above, but additional lengths are also considered. Be done. In one example, a coil with a length of about 9.5 cm was formed. The material used to build the coil 413 can be a polymer, such as an elastic material such as plastic or rubber. In yet another example, the coil 413 can be made from a metal or alloy such as titanium, stainless steel or shape memory alloy. In an exemplary embodiment, the coil 413 was formed using stainless steel.

13A and 13B show end views and side views of the first end piece 431, respectively, where the first end piece 431 is, in some examples, of the capsules shown in FIGS. 11A and 11B. Form a third portion 407. As shown in FIG. 13, the first end piece 431 is usually formed as a cylinder defining the first inner surface 433 and outer surface 435. FIG. 13B shows the first end piece 431 in a side view. As shown in FIG. 13B, the outer surface 435 has an outer diameter 439 of a first end piece 431 that can match the outer diameter 411 of the third portion 407 described with reference to FIGS. 11A and 11B. Define. The first inner surface 433 of the first end piece 431 also defines a first inner diameter 441 that matches the inner diameter of the third portion 407 described with reference to FIGS. 11A and 11B. As shown, the first end piece 431 has a second inner surface 437 defining a second inner diameter 443 that can be sized to fit around the coil 413 shown in FIG. 12B, such as along the outer surface 427. include. In some embodiments, the first end piece 431 can be funnel-shaped with an inner diameter widest near the opening 409 and tapered to an inner diameter that tapers further away from the opening 409.

14A and 14B show end views and side views of the second end piece 445, respectively, where the second end piece 445 is, in some examples, of the capsules shown in FIGS. 11A and 11B. A second portion 408 is formed. As shown in FIG. 14A, the second end piece 445 is substantially circular when viewed along the central longitudinal axis. The second end piece 445 usually defines a first inner surface 447 that tapers along the central longitudinal axis.

FIG. 14B shows a side view of the second end piece 445. As shown in FIG. 14B, the second end piece 445 has a first end 457, a second end 461, and a second portion 408 described with reference to FIGS. 11A and 11B. A first outer diameter 449 that corresponds to the outer diameter 422 of the above is defined. As shown in FIG. 14B, the first outer diameter 449 is tapered to be wider at the portion closest to the first end 457 and thinner at the portion closer to the second end 461. The second end piece 445 is smaller than the first outer diameter and is sized to fit within the coil 413 shown in FIGS. 12A and 12B, such as in the lumen defined by the inner surface 425 of the coil. It has a second outer diameter of 451. As shown, the second end piece 445 has a first inner diameter 453 along a portion close to the first end 457 and a second inner diameter 455 along a portion closer to the second end 461. And delimit. The first inner diameter 453 can match the inner diameter 426 of the capsule shaft 232 shown in FIG. The second inner diameter 455 is sized to match the outer diameter 424 of the capsule shaft 232 shown in FIG. 10 so that the capsule shaft 232 can be placed within the second end 461 of the second end piece 445. Can be.

In some embodiments, the first end piece 431 and / or the second end piece 445 is a nylon, polycarbonate, polyethylene, polyethylene terephthalate, polyacetal, polyformaldehyde, trade name Delrin (registered). It can be made from polymers such as polyoxymethylene, such as those sold under the trade name (trademark), or polyether block resins, such as those sold under the trade name Pevax®. In addition or instead, the faces of the first end piece 431 and / or the second end piece 445, such as the first inner surface 433 and / or the outer surface 435 of the first end piece 431, are Materials that do not adhere or have a low coefficient of friction, such as silicon, FEP or Teflon ™, can also be included.

In a particular example, the capsule 230 shown in FIGS. 11A and 11B is shown in FIGS. 12A and 12B with the coil shown in FIGS. 12A and 12B, the first end piece 431 shown in FIGS. 13A and 13B, and FIGS. 14A and 14B. It is formed by assembling the second end piece 445. For example, in the first end piece 431, one end of the coil 413 is the first end portion in a state where the outer surface 427 of the coil 413 is adjacent to the second inner surface 437 of the first end piece. By inserting it into the piece 431 or the like, it can be arranged so as to surround the length portion of the coil 413. The second end piece 445 can be arranged inside the length portion of the coil 413 by inserting the first end 457 of the second end piece 445 into the coil 413 and the like. In this configuration, the first end piece 431 defines an inward opening 409 of the capsule 230 shown in FIG. 12B.

In the embodiment of the capsule 230 with the cover 415 shown in FIG. 11B, the cover 415 can be integrated with the first end piece 431 and, in addition or instead, the second end piece 445. Can be integrated with. That is, the first end piece 431 can be integrally formed with the cover 415 so as to be a continuous single body having the cover 415. The first end piece 431 can be integrally formed with the cover 415 so that the capsule 230 has a smooth continuous surface along the inside and outside. The second end piece 445 can also be integrally formed with the cover 415 so as to be continuous with the cover 415. The inner diameter of the capsule 230 is due to the inner diameter of the first inner diameter 441 and / or the coil 413 of the first end piece 431 and / or in some cases, for example, when the cover 415 is on the inner surface of the coil 413. It can be defined by a cover. The outer diameter of the capsule 230 is due to and / or a portion of the outer diameter of the first end piece 431, the outer diameter of the coil 413 and / or the first outer diameter of the second end piece 445. In the example of, for example, when the cover 415 is on the outer surface of the coil 413, it can be defined by the cover 415. In some examples, the inner diameter of the capsule 230 is about 0.50 cm, about 1.0 cm, about 1.5 cm, about 2.0 cm or any pair of values described above, but additional thickness is also considered. Be done. In one example, a capsule with an inner diameter of about 1.1 cm was formed. In some examples, the outer diameter of the capsule 230 is about 0.8 cm, about 1.2 cm, about 1.7 cm, about 2.1 cm or any pair of values described above, but also with additional thickness. Conceivable. In one example, a capsule with an outer diameter of about 1.5 cm was formed.

For example, the capsule 230 described herein, including a coil 413, or an alternative structure such as a braided or woven material, can bend or bend along a longitudinal axis. During the removal process, the capsule 230 can be inserted into a body cavity such as the patient's throat, esophagus, stomach or intestine. If the capsule 230 can bend or bend, the capsule 230 will be easier to operate when inserted or retracted from inside the body cavity compared to a capsule that cannot bend or bend. The capsule 230, which can bend or bend, can contribute to the user more easily manipulating the capsule 230 in the body cavity, for example by bending or bending in the patient's throat or esophagus. The bendable or flexible capsule 230 can also contribute to the user more easily manipulating the capsule 230 through the body cavity when the object is placed within the capsule 230. Alternatively, the capsule 230 with a particular surface formed from a material with a low coefficient of friction can contribute to facilitating the unfolding or unloading process. For example, if a coating containing a non-adherent or low-adhesive material such as fluorocarbon such as silicon or Teflon ™ is on the leading edge and / or inner surface of the capsule 230, the object will be such. It can be pulled into the capsule 230 or unfolded from inside the capsule than if it had no coating. As a further example, if a coating containing a non-adherent or poorly adherent material is on the outer surface of the capsule 230, the capsule 230 is inserted into or withdrawn from the body cavity more than such an uncoated capsule 230. be able to.

15A-15B are side views of various exemplary capsules, showing additional features that can be included, for example, in the capsule 230 above. FIG. 15A is a side view of a capsule 465 having a catheter 467 and including a tip 469, the tip 469 which may be included in the inward opening of the capsule 465. In some examples, the tip 469 can be placed in the opening 409 of the capsule 230 shown in FIG. In some embodiments, the tip 469 can form a transition around the capsule 465 so that the capsule 465 can more easily advance along a path of travel, such as in the lumen. The tip 469 can form a tapered transition from the tip of the capsule 465 to the outer diameter of the capsule 465 and can function as a wedge to facilitate insertion of the capsule 465 into the lumen. .. The tip 469 can also cover the opening of the capsule 465 to prevent an object from entering the capsule 465 as the capsule advances along a path of travel, such as being inserted into a lumen. In some examples, the capsule 465 is used to deploy the device from within the capsule 465. For example, the anchor 110 and / or sleeve 120 shown in FIG. 4 can be deployed from inside the capsule 465. When the capsule 465 is unfolded, the tip 469 may be removed to allow the device to unfold from inside the capsule 465.

15B and 15C show various exemplary structures of tips and capsules that can facilitate removal of the tips from the capsule. FIG. 15B shows a capsule 477 with a tip 479 that can be formed from a plurality of pieces such as a woven material or a plurality of ribs. Since the tip tool 479 can be crushed, it can be reduced in size and contribute to fitting the tip tool 479 inside the capsule 477. When the capsule 477 is unfolded, the tip tool 479 can be removed from the opening of the first end of the capsule 477 by crushing the tip tool 479 and storing it in the capsule 477. For example, the tip 479 can be crushed with a catheter 467 and guided into the capsule 477. FIG. 15C shows a further example of a capsule 481 having a tip 483 that can be formed as a single medium entity. The tip 483 can be attached to the capsule 481 with a fastener 485, such as a string or clip. When the capsule 481 deploys, for example, in the patient's body cavity, the tip 483 removes from the opening of the first end of the capsule 481 by releasing the fastener 485 and detaching the tip 483 from the capsule 481. Can be done. For example, the fastener 485 may be a sewing thread connecting the tip 483 to the capsule 481. The sewing thread can be cut or unwound to separate the tip 483 from the capsule 481, and then the tip 483 can be separated from the capsule 481 and dropped from the catheter 467.

16A and 16B show various additional structures of tips and capsules that can be removed from the opening of the capsule to facilitate deployment of the device from inside the capsule. FIG. 16A shows a capsule 491 containing a tip tool 493 configured to split into multiple pieces when the capsule 491 unfolds, such as when the capsule 491 is placed in a patient's body cavity. The tip tool 493 can be connected to an external device such as a leash (not shown) that can be used to allow the tip tool 493 to crack and fall from the capsule 491. FIG. 16B shows, for example, a capsule 495 containing a tip 497 that can be pulled back from the opening of the capsule 495 when the capsule 495 is unfolded. The tip 497 can be maintained in a closed position covering the opening of the capsule 495, for example using a spring. To remove or open the tip 497, the tip 497 can be controlled by a pull-back device such as a leash 499 to pull the tip 497 back beyond the capsule 495. In this example, by pulling the tip 497 back over the capsule 495, the tip 497 opens the inside of the capsule 495 and allows access to the inside of the capsule 495.

17A and 17B show various additional structures of tips and capsules that can be removed from the opening of the capsule to facilitate deployment of the device from inside the capsule. FIG. 17A shows a capsule 501 containing a tip tool 503, the tip tool 503 being formed from a plurality of portions that can be connected to each other to form the tip tool 503. For example, the tip 503 can include a first portion 505, the first portion 505 closing the tip 503 at the opening by attaching the first portion 505 to the rest of the tip 503. It is held in place around the opening of the capsule 501 to keep it in place. The first portion 505 can be glued or sutured to, for example, the rest of the tip tool 503. FIG. 17B shows a capsule 501 from which the tip 503 is removed from the opening of the capsule 501. When the capsule 501 unfolds, the tip tool 503 can be removed from the opening of the capsule 501, for example, by advancing the capsule 501 through the tip tool 503 and separating each portion of the tip tool 503 from each other. .. For example, the capsule 501 can advance through the tip tool 503 and break the sewing thread or glue connecting the first portion 505 to the rest of the tip tool 503. After each portion of the tip tool 503 is separated from each other, the capsule 501 can be further advanced to be inserted into the tip tool 503 and the tip tool 503 can be removed from the opening of the capsule 501.

18A-18C show various further structures of the tip and capsule, which can be used to deploy the device from inside the capsule without removing the tip from the opening of the capsule. can. For example, the gastrointestinal device 100 with the sleeve 120 and the anchor 110 shown in FIG. 4 can be deployed from inside the capsule using the devices described herein. FIG. 18A shows a capsule 507 containing a tip 509 formed from a portion 511, the portions 511 combined to form a tip 509. For example, the tip 503 can include a portion 511 made of a flexible or elastic material such as cloth, plastic or rubber. The tip 509 forms a transition from the catheter to the larger diameter of the capsule 507 and facilitates insertion of the capsule 507 into the patient's body cavity. FIG. 18A shows a capsule 507 and a tip 509 in which a portion of the sleeve 120 is placed, for example, between portions 511 of the tip 509 through an opening in the tip 509. In this configuration, the anchor is held in the capsule 507 in a collapsed configuration when the capsule 507 is inserted into the body cavity. FIG. 18B shows the sleeve 120 removed from the capsule 507 and the partially unfolded anchor 110. As shown in FIG. 18B, the portions 511 of the tip tool 509 can be separated from each other and can move outward through the opening of the capsule 507. In this example, the tip 509 allows the anchor 110 to pass through the tip and allows the anchor 110 to deploy from inside the capsule 507 without removing the tip 509 from the capsule 507. As shown in FIG. 18C, the tip portion 132 unfolds from the capsule 507 and extends outside the capsule 507. The rest of the anchor 110 can also be deployed from inside the capsule 507 without removing the tip 509. In this example, the capsule 507 is used to pull the tip 509 back from the opening of the capsule 507 without separating the tip 509 from the capsule 507, and without the need for a mechanism to pull the tip 509 back from the opening of the capsule 507, the sleeve 120 and the anchor 110 shown in FIG. The gastrointestinal device 100 having the above can be deployed in the patient's body. In this example, the tip tool 509 is formed as a single unit with slits that, when the anchor 110 is pushed through the tip tool 509, tears to allow portions 511 of the tip tool 509 to separate from each other. Can be done. Thus, the tip 509 is a continuum as the capsule 507 advances through the body cavity, and then the tip 509 opens when the anchor 110 unfolds.

FIG. 19 is a schematic cross-sectional view of the handle 234 shown in FIG. The handle 234 may include a feature that moves the hook assembly 210 shown in FIGS. 9A and 9B with respect to the capsule assembly 212 shown in FIG. In some embodiments, the handle 234 facilitates advancing or retracting the hook assembly 210 with respect to the capsule assembly 212, such as by pulling the first end 310 of the hook cable 220 into the capsule 230 shown in FIG. Includes featured parts. In some embodiments, the handle 234 can be configured to convert the rotational movement into a longitudinal movement in order to move the capsule assembly 212 and / or the hook assembly 210 longitudinally with respect to each other.

As described above, the handle 234 has a first end 420, a second end 421, a first control knob 436 located at the first end 420, and a second end 421. It has a second control knob 438 and a central core 440 arranged in. Handle 234 defines a longitudinal axis along the length of handle 234.

As shown in FIG. 19, the first control knob 436 has an inner surface 450 and an outer surface 452. The inner surface 450 of the first control knob 436 defines the inner diameter, and the outer surface 452 defines the outer diameter 448. In some embodiments, the outer diameter 448 of the first control knob 436 can vary along the circumference of the outer surface 452 of the first control knob 436. That is, the first control knob 436 can have a feature along the outer surface 452 that protrudes or undulates from the outer surface 452 of the first control knob 436. Specific features can be provided along the outer surface 452 of the first control knob 436 to facilitate gripping by the user when rotating the first control knob 436 circumferentially with respect to the central core 440. To be sized and / or shaped.

As shown in FIG. 19, the first control knob 436 has a first portion 446 having a first inner diameter and a second portion 480 having a second inner diameter wider than the inner diameter of the first portion 446. Can have. The inner diameter along the first portion 446 of the first control knob 436 can be sized to fit the second sheath 442. The inner diameter along the second portion 480 of the first control knob 436 can be sized to fit a portion of the central core 440. In some embodiments, the inner surface 450 of the first control knob 436 can be threaded near the first end 420 of the handle 234 and at least along the first portion 454 of the inner surface 450. The inner surface 450 of the first control knob 436 may be smooth along the second portion 456 of the inner surface 450 of the first control knob 436 near the central core 440. The first portion 454 of the inner surface 450 of the first control knob 436 can be threaded, and the screw has a higher thread crest along the inner surface than the surface of the second portion 456, which is smooth. Have. That is, the screw of the first portion 454 can have a top that extends further inward in the radial direction than the surface of the second portion 456.

As shown in FIG. 19, the second control knob 438 has an inner surface 460 defining an inner diameter and an outer surface 462 defining an outer diameter 466. In some embodiments, the outer diameter 466 of the second control knob 438 can vary along the circumference of the outer surface 462 of the second control knob 438. That is, the second control knob 438 can have a feature along the outer surface 462 that projects or undulates from the outer surface 462. Specific features can be provided along the outer surface 462 of the second control knob 438 to facilitate gripping by the user when rotating the second control knob 438 circumferentially with respect to the central core 440. Can be of a size and / or shape.

As shown in FIG. 19, the second control knob 438 has a first portion 464 having a first inner diameter and a second portion having a second inner diameter wider than the first inner diameter of the first portion 464. It can have a portion 482 and. The second control knob 438 is sized to fit a first inner diameter along the first portion 464 and a portion of the central core 440, sized to fit the third sheath 444. It can have a second inner diameter along the second portion 482. In some embodiments, the inner surface 460 may be smooth along the first portion 486 of the inner surface 460, near the central core 440. The inner surface 460 of the second control knob 438 can be threaded near the second end 421 of the handle 234 and at least along the second portion 468 of the inner surface 460. The threaded second portion 468 can have a screw containing a higher top than the smooth first portion 486 of the inner surface 460. That is, the screw of the second portion 468 can have a top extending radially inward from the surface of the first portion 486.

As shown in FIG. 19, the central core 440 has a first end 494, a second end 496, an outer surface 471 and an inner surface 476. The outer surface 471 defines an outer diameter 472 and the inner surface 476 defines an inner diameter 474. The inner surface 476 of the central core 440 can be threaded. In some examples, the inner surface 476 can be smooth. For example, the inner surface 476 can be threaded to engage a screw along the outer surface of the second sheath 442. In some examples, the inner surface 476 is smooth and the inner diameter 474 is wide enough to slide the second sheath 442 into the central core 440.

As shown in FIG. 19, the first end 494 of the central core 440 has a fitting portion corresponding to a second portion 456 of the inner surface 450 of the inner surface 450 of the first control knob 436, such as a protrusion or protrusion. The holding feature portion 488 of 1 can be included. The first holding feature 488 can hold the first control knob 436 on the central core 440, while the first control knob 436 does not disengage from the central core 440 with respect to the central core 440. Allows to rotate or turn. The second end 496 of the central core 440 has a second holding feature 490, such as a protrusion or protrusion, having a fitting corresponding to the first portion 486 of the inner surface 460 of the second control knob 438. Can have. The second holding feature portion 490 can hold the second control knob 438 on the central core 440, and the second control knob 438 does not disengage from the central core 440 with respect to the central core 440. Allows to rotate or turn.

As shown in FIG. 19, the central core 440 has an outer diameter at the first end 494 that is sized to fit within the inner diameter of the second portion 480 of the first control knob 436. The central core 440 has an outer diameter at the second end 496 that is sized to fit within the inner diameter of the second portion 482 of the second control knob 438. The first end 494 of the central core 440 is located within the second portion 480 of the first control knob 436 and the second end 496 of the central core 440 is the second of the second control knob 438. It is arranged in the portion 482 of.

FIG. 20 is a schematic side sectional view of the handle 234 of FIG. 10 showing a particular feature. As shown, the handle 234 includes a second sheath 442 and a third sheath 444. The second sheath 442 has a substantially cylindrical shape having a first end 510, a second end 512, and a length portion 514 in between. The second sheath 442 has an outer surface 518 defining an outer diameter 516 and an inner surface 522 defining an inner diameter 520. In some embodiments, the first end 510 of the second sheath 442 can be attached to the second end 416 of the capsule shaft 232. As shown, the outer diameter 516 of the second sheath 442 is sized to fit within the inner diameter 474 of the central core 440 shown in FIG. The outer surface 518 of the second sheath 442 can be threaded. The outer surface 518 can be threaded at the same pitch as the screw disposed on the first portion 454 of the inner surface 450 of the first control knob 436. For example, the inner surface 450 of the first control knob 436 can have a female thread, and the outer surface 518 of the second sheath 442 is of the first control knob 436 such as a screw on the first portion 454 of the inner surface 450. It can have male threads with the same pitch as the threads on the inner surface 450. In some embodiments, the inner surface 522 of the second sheath 442 may be smooth.

As shown, the third sheath 444 has a substantially cylindrical shape with a first end 530, a second end 532, and a length portion 534 in between. The third sheath 444 has a first portion 538, the first portion 538 defines a first outer diameter along a portion of the length portion 534 of the third sheath 536. Have. As shown in FIG. 20, the second end 532 of the third sheath 444 has a second outer diameter smaller than the first outer diameter along the first portion 538 of the third sheath 444. It has a portion 550. In some embodiments, the second portion 550 has a threaded outer surface 554. The third sheath 444 has a third portion 552 with a smooth outer surface 556. A portion of the third portion 552 is tapered so that the outer diameter of the portion of the third portion 552 shifts from the first diameter, which is the same diameter as the second portion 550, to a smaller final diameter. It is a transition portion 558 having a reduced outer diameter. A portion of the third portion 552 includes a slot 568 parallel to the longitudinal axis of the handle 234 formed through the width of the third portion 552.

The first outer diameter along the first portion 538 of the third sheath 444 is sized to be accommodated within the first inner diameter portion of the second portion 550 of the second control knob 438. In some embodiments, the first outer diameter along the first portion 538 of the third sheath 444 is sized to be accommodated within 520 parts of the inner diameter of the second sheath 442. In some embodiments, the first surface 536 of the first portion 538 of the third sheath 444 is threaded. The first surface 536 of the third sheath 444 can be threaded at the same pitch as the threads on the second portion 468 of the inner surface 460 of the second control knob 438. For example, the second portion 468 of the inner surface 460 of the second control knob 438 can have a female thread, and the outer surface of the first portion 538 of the third sheath 444 is the inner surface 460 of the second control knob 438. It can have a male screw with the same pitch as the female screw above.

As shown in FIG. 20, the third sheath 444 includes a first portion 540 with a first inner surface 541 and a second portion 542 with a second inner surface 543. In some embodiments, the first inner surface 541 and / or the second inner surface 543 defines a first inner diameter of a portion of the third sheath 444. The first inner diameter of the third sheath 444 is sized to accommodate the hook assembly 210 shown in FIGS. 9A and 9B. For example, the third sheath 444 can have a wider inner diameter than the outer diameter of the hook assembly 210. The first inner surface 541 and / or the second inner surface 543 of the third sheath 444 can be relatively smooth. In some examples, when the hook assembly 210 is unfolded, the hook assembly 210 can be slidably accommodated within the third sheath 444. In some embodiments, the first inner diameter of the third sheath 444 defines the innermost diameter of the handle 234. That is, the third sheath 444 is the innermost portion in the radial direction of the handle 234, and the first inner diameter along the first portion 540 of the third sheath 444 defines the inner diameter of the handle 234.

In some examples, the screws on the outer surface 518 of the second sheath 442 and the first surface 536 of the third sheath 444 depend on each rotation of the first control knob 436 and the second control knob 438. , The second sheath 442 and the third sheath 444 have an appropriate pitch angle to advance the third sheath 444 by an appropriate distance in the longitudinal direction. The pitch angle of the screws on the second sheath 442 and the third sheath 444 is also such that when the first control knob 436 and the second control knob 438 are rotated, an appropriate amount of force is applied to the second in the longitudinal direction. It can be sized to be transmitted to the pods 442 and the third pod 444. The pitch angle of the screws on the second sheath 442 and the third sheath 444 also has a specific amount of rotational movement of the first control knob 436 and the second control knob 438, the capsule assembly 212 and / or the hook assembly 210. Can be sized to provide an appropriate amount of longitudinal motion to advance the central core 440. In some embodiments, the handle 234 converts the rotational force applied to the first control knob 436 and the second control knob 438 into a longitudinal force with respect to the second sheath 442 and / or the third sheath 444. It is configured as follows. Longitudinal forces acting on the second sheath 442 and / or the third sheath 444 extend the second sheath 442 and the third sheath 444 from each other and the capsule assembly 212 and hook assembly 210 into the central core 440. Is extended in the longitudinal direction. Longitudinal forces acting on the capsule assembly 212 and hook assembly 210 can range from about 5.0 lb force (22.2 Newton) to about 25.0 lb force (111.2 Newton). In some examples, the longitudinal force acting on the capsule assembly 212 and hook assembly 210 can be from about 5.0 lb force (22.2 Newton) to about 35.0 lb force (155.7 Newton). .. For example, the longitudinal force acting between the capsule assembly 212 and the hook assembly 210 is about 5.0 pound force (22.2 Newton), 10.0 pound force (44.5 Newton) or about 15.0. Pound force (66.7 Newton) to about 25.0 Pound force (111.2 Newton), 30.0 Pound force (133.4 Newton) or about 35.0 Pound force (155.7 Newton), or as described above. It can be a force between any pair of values, but further values are envisioned.

As used herein, a "screw" or "thread" is defined as a ridge that covers a cylinder or cone in the shape of a spiral. As used herein, "pitch" is defined as the distance between the top of one screw and the next. As used herein, a "lead" of a screw is defined as the distance along the longitudinal axis in which the screw travels in response to one complete rotation of the screw. That is, the lead of the screw is the length that the screw moves along the screw axis when the screw completes a 360 ° rotation. As used herein, the "pitch angle" is the angle of the screw in the horizontal cross section of the screw. The pitch angle can also be expressed as the ratio of the longitudinal distance the screw travels divided by the diameter of the screw in response to a complete rotation of the screw at 360 °.

21A shows a side view of a schematic view of the second end 532 of the third sheath 444 shown in FIG. 20. As shown in FIG. 21A, the second end 532 of the third sheath 444 is at the second end 532 from the first outer diameter 560, which is the same size as the diameter of the second portion 550. It can have a transition portion 558 with a diameter that shrinks to a thinner second outer diameter. The transition portion 558 of the second end 532 of the third sheath 444 can have a smooth outer surface. The transition portion 558 can include a slotted elongated portion having a slot 568 that penetrates the second end 532 of the third sheath 444 and extends a distance along the length of the transition portion 558. .. The slot 568 can be formed over the entire outer shape of the outer surface 556 of the third sheath. That is, slot 568 divides the second end 532 of the third sheath 444 into protrusions 570 or finger-like bodies, and slot 568 is between the protrusions 570.

FIG. 21B shows a further side view of a schematic of a third sheath 444 near the second end 532. As shown in FIG. 21B, the second end 532 of the third sheath 444 can include a hook assembly lock 580. The hook assembly lock 580 includes a cap 582 having a first end 584, a second end 586, and an outer surface 588 defining an outer diameter. The outer surface 588 may include certain features, such as protrusions, that allow the user to rotate the hook assembly lock with respect to the third sheath 444. The outer diameter of the cap 582 is larger than the inner diameter 564 of the second control knob 438 shown in FIG. The hook assembly lock 580 defines a first inner surface 590 defining a first inner diameter near the first end 584, a second inner surface 592 defining a second inner diameter, and a third inner diameter. It has a third inner surface 594. In some embodiments, the first inner surface 590 of the cap 582 is threaded with the same threads as the outer surface 554 of the second portion 550 of the third sheath 444. As shown, the third inner surface 594 of the cap 582 is from the first diameter, which is the same as the second inner diameter of the cap 582, to the smaller final inner diameter near the second end 586 of the cap 582. It is tapered so that the width is reduced. As shown, the second inner surface 592 and the third inner surface 594 of the cap 582 are smooth.

As already described with reference to FIG. 20, the third sheath 444 has a second portion 550 with a threaded outer surface 554 and a third portion 552 with a smooth outer surface 556. As shown in FIG. 21B, in order to engage the hook assembly lock 580, the cap 582 is placed over the second end 532 of the third sheath 444 and rotated to rotate the third sheath 444. Engage with a screw on the outer surface 554. The cap 582 is rotated to screw in the cap 582 covering the second end 532 of the third sheath 444 and cap along the third sheath 444 from the second end 532 to the first portion 538. The 582 can be advanced. When the cap 582 advances along the third sheath 444 near the second end 532, the taper of the third inner surface 594 of the cap 582 causes the second end 532 of the third sheath 444 to have a radius. It is compressed inward in the direction, and the size of the inner diameter of the second end 532 of the third sheath 444 becomes smaller. As the protrusion 570 shrinks inward, the second inner surface 543 can be pressed against an object located within the inner diameter of the third sheath 444, such as the hook assembly 210. In the example shown in FIG. 21B, the hook assembly lock 580 is used in the same manner as the base. It is also envisioned that the hook assembly lock 580 may include alternative configurations such as clamps or clasps to lock the hook assembly 210 to the third sheath 444 at the second end 532.

22A and 22B show side views of the handle 234 at various deployment stages with several uses. The handle 234 expands from the stowed configuration shown in FIG. 20 to the stretched or stretched configuration shown in FIGS. 22A and 22B by extending the second sheath 442 and the third sheath 444 away from the central core 440. be able to. FIG. 22A shows the third sheath 444 in an unfolded state, and FIG. 22B shows the second sheath 442 in an unfolded state. The second sheath 442 and the third sheath 444 extend from the central core 440 by rotating one or both of the first control knob 436 and the second control knob 438.

As shown in FIG. 22A, the second control knob 438 has a first portion 486 of an inner surface 460 that is in contact with a second end 496 of the central core 440. Smoothing the surface of the first portion 486 allows the second control knob 438 to rotate relative to the central core 440 without moving longitudinally with respect to the central core 440. When the second control knob 438 rotates with respect to the central core 440, the screw on the second portion 468 of the inner surface 460 of the second control knob 438 becomes the screw on the first surface 536 of the third sheath 444. Engage with and advance or retract the third sheath 444 from the central core 440 along the longitudinal axis. By rotating the second control knob 438 circumferentially with respect to the central core 440, the third sheath 444 extends or retracts along the longitudinal axis of the handle 234 with respect to the central core 440.

As shown in FIG. 22B, the first control knob 436 has a smooth second portion 456 of the inner surface 450 in contact with the first end 494 of the central core 440. The first control knob 436 can rotate relative to the central core 440 without moving longitudinally with respect to the central core 440. As the first control knob 436 rotates with respect to the central core 440, the screw on the first portion 454 of the inner surface 450 of the first control knob 436 engages the screw on the outer surface 518 of the second sheath 442. , The second sheath 442 is advanced or retracted along the longitudinal axis. By rotating the first control knob 436 circumferentially with respect to the central core 440, the second sheath 442 extends or retracts along the longitudinal axis of the handle 234 with respect to the central core 440.

In some embodiments, the second sheath 442 is configured to extend from about 25.4 mm (1.0 inch) to about 127 mm (5.0 inch) away from the central core 440. That is, the second sheath 442 can extend from the central core and extend the overall length of the handle 234 by 25.4 mm (1.0 inch) to about 127 mm (5.0 inch). In some embodiments, the third sheath 444 is configured to extend from the central core 440 by about 25.4 mm (1.0 inch) to about 127 mm (5.0 inch). That is, the third sheath 444 can extend from the central core and extend the overall length of the handle 234 by 25.4 mm (1.0 inch) to about 127 mm (5.0 inch).

In one example, a handle 234 was made. As an example, a first control knob 436 with a screw pitch of 2.50 mm, a screw lead of 5.0 mm, and an inner diameter of 21.40 mm was formed. As an example, a second control knob 438 with a screw pitch of 2.50 mm, a screw lead of 5.0 mm, and an inner diameter of 14.0 mm was formed. As an example, a cap 582 with a screw pitch of 2.50 mm, a screw lead of 5.0 mm, and an inner diameter of 11.4 mm was formed.

The systems disclosed herein use one or more screws to provide devices and methods for converting rotational movements into longitudinal movements. This configuration has been found to provide a high controllable mechanical force along the longitudinal axis. The devices disclosed herein allow the user to transmit high mechanical force to the remote end of a long device such as a ejector containing a lumen and are attached to a capsule or lumen. Provided is a device that allows a user to attach and remove an object by receiving the object in the catheter. The first control knob 436 and the second control knob 438 rotate the rotation motion applied to the first control knob 436 and the second control knob 438 in a linear motion of the second sheath 442 and the third sheath 444, respectively. Or it is configured to convert to longitudinal motion.

In one example, as shown in FIG. 8, in the unfolded configuration, the hook assembly 210 shown in FIGS. 9A and 9B can be slidably accommodated within the capsule assembly 212 shown in FIG. The hook assembly lock 580 can be used to lock the hook assembly 210 to the handle 234. For example, as described with reference to FIG. 9B, the hook cable 220 can first be inserted into and locked into the hook sheath 222. The hook assembly 210 can then be slidably accommodated within the handle 234, and the hook assembly lock 580 engages the hook assembly 210 at the second end 532 of the third sheath 444 to engage it. Can be locked. With the hook assembly 210 locked to the second end 532 of the third sheath 444, the second end 532 of the third sheath 444 towards or away from the central core 440. By moving, the hook assembly 210 slides against the rest of the capsule assembly 212. Also, with the hook assembly 210 locked to the second end 532 of the third sheath 444, the first end 510 of the second sheath 442 towards or away from the central core 440. By moving in the direction, the capsule shaft 232 and the capsule 230 slide with respect to the hook assembly 210. In an exemplary method of deployment, with the hook assembly 210 locked to the second end 532 of the third sheath 444, the second control knob 438 is rotated to pull the mounting feature 340 into the capsule 230. The first control knob 436 can be rotated to advance the capsule 230 covering the mounting feature 340.

The take-out device 200 described above can be used for taking out an anchor device such as the anchor 110 of the gastrointestinal device 100 already shown in FIGS. 1 to 7. In a further example, the extraction device 200 and method for removing the anchor device disclosed herein can be used for further or alternative applications such as removal of a stent or foreign body from inside the patient's gastrointestinal tract. Can be done. The devices and methods disclosed herein have certain advantages, such as the ability to exert large forces in both capturing foreign matter and storing foreign matter within capsules such as the capsule 230 described above. Bring. This advantage is that foreign bodies such as stents are large and the user attempts to retrieve the object in a small tube or capsule to remove it from the patient's body, or a device such as a stent is implanted in the patient's tissue. Especially useful when it has to be removed.

In one example, an exemplary gastrointestinal implant can be in both dilated and dilated configurations. The gastrointestinal implant can be held in place within the patient's pylorus by using the anchor 110 as shown in FIG. As already described with reference to FIG. 6, the anchor can be formed from a hollow tubular braided structure that can be placed in the patient's digestive system and taken into a collapsed configuration for removal from the digestive system. can. In some embodiments, the ejector 200 can be used to remove the anchor 110 from the patient's body. For example, the extraction device 200 can be used to remove the anchor from the patient's stomach, pylorus or intestine. Although described herein in connection with removing a gastrointestinal device from the patient's pylorus, the methods disclosed herein use the devices disclosed herein and use similar steps. It can be used to remove foreign objects or objects from inside the patient.

23-27 show the unloading device 200 at various stages of deployment to further illustrate the method of deployment. Devices such as the gastrointestinal device 100 shown in FIG. 7 located inside the patient can be endoscopically removed through the patient's esophagus, throat, etc. using the deployment method described herein. can. The gastrointestinal apparatus 100 can be removed from inside the patient without performing surgery, eg, without incising the patient's body, using the deployment method described herein.

FIG. 23 shows the gastrointestinal device 100 placed in the patient's body, described with reference to FIG. 7, with an anchor 110 placed in the pylorus 20 between the stomach 16 and the intestine 18. In some examples, the endoscope 600 can be used to see the position of the anchor 110 and the drawstring 192. The tube of the endoscope 600 can also be used to guide the hook assembly 210 and the mounting feature 340 towards the drawstring 192 of the anchor 110. The mounting feature 340 can then be coupled to the drawstring 192 and the mounting feature 340 can be pulled into the hook sheath 222 to crush the proximal end 130.

FIG. 24 shows the capsule assembly 212 and the hook assembly 210 after the endoscope 600 has been removed from inside the patient. The mounting feature 340 is coupled to the drawstring 192 and the endoscope 600 is replaced by the capsule assembly 212 away from the perimeter of the hook assembly 210. The capsule assembly 212 can be placed over the hook assembly 210 by inserting a second end (312 of the hook cable 220 shown in FIG. 9A) into the opening 409 of the capsule 230, wherein the capsule assembly 212 is a capsule. The hook assembly 210 can be moved forward in the patient's body until the 230 is placed near the mounting feature 340. The capsule assembly 212 can be placed with the opening 409 of the capsule 230 placed near the proximal portion 130 and with the opening 409 of the capsule 230 in contact with the proximal portion 130. be able to. The mounting feature 340 can be retracted into the capsule 230 by, for example, pulling a second end (312 shown in FIG. 9A) of the hook assembly 210 that remains outside the patient. The mounting feature portion 340 is retracted into the capsule 230 and can retract the proximal end portion 130 until the proximal end portion 130 contacts the opening 409 of the capsule 230. By pulling the mounting feature portion 340 into the capsule 230 while the proximal end portion 130 remains outside the capsule 230, the drawstring 192 is pulled in from the proximal end portion and the proximal end portion 130 is crushed in the radial direction. When the proximal end portion 130 is crushed and the outer diameter is smaller than the inner diameter of the capsule 230, the proximal end portion 130 can be pulled into the capsule 230 by further pulling in the hook assembly 210 passing through the capsule assembly 212.

FIG. 25 shows the anchor 110 after the proximal portion 130 has been drawn into the capsule 230. As shown, the neck portion 134 is of suitable size to be retracted into the capsule 230. Alternatively, the capsule 230 can be pushed to cover the neck portion 134. For example, holding the hook assembly 210 (shown in FIG. 9A) still attached to the anchor 110 by the attachment feature 340, while pushing the capsule assembly 212 along the longitudinal axis pushes the capsule 230 to the anchor 110. Covers and covers the neck portion 134.

FIG. 26 shows the capsule 230 after the capsule 230 has been pushed to cover the neck portion 134 of the anchor 110 and the rest of the anchor 110 such as the tip portion (132 shown in FIG. 4). As shown, the capsule 230 can be pushed through, for example, the pylorus 20 until it enters the intestine 18. In some examples, the capsule 230 can be pushed to cover the tip portion (132) and crush the tip portion 132. The capsule 230 can be pushed through the pylorus 20 surrounding the capsule 230, surrounding the tip portion (132) of the anchor 110 and crushing the tip portion.

FIG. 27 shows a gastrointestinal device 100 being recovered from a patient. The gastrointestinal device 100 can be pulled out of the patient by pulling in the capsule assembly 212 and pulling in the capsule 230 with an anchor placed inside. By pulling in the anchor 110, the sleeve 120 attached to the anchor 110 is pulled in. The gastrointestinal device 100 can be withdrawn from the patient through the patient's esophagus and throat.

FIGS. 28-39 show the above unloading device 200 at various stages of deployment to illustrate its use. 28-39 are insets showing the various steps that can be used, showing each part of the patient's internal ejector 200, and the deployment steps from different perspectives, such as different angles inside the patient. And / or includes an inset from the outside of the patient showing deployment steps for manipulating the portion of the ejector 200 that remains outside the patient.

FIG. 28 shows the anchor 110 described with reference to FIG. 6 placed in the pylorus between the stomach and intestines within the patient's body. As shown in FIG. 28, in some embodiments, the endoscope 600 can be inserted into the patient and the endoscope 600 can be used to visually recognize the positions of the anchor 110 and the drawstring 192. .. FIG. 28 includes an inset view, which is another view from the viewpoint of the endoscope. The drawstring 192 can be incorporated within the proximal portion 130 to implement a method of crushing the proximal portion 130 and / or the anchor 110.

FIG. 29 shows a hook assembly 210 including a hook cable 220 inserted into an endoscope tube. The endoscope 600 can be used to guide the mounting feature 340 while visually recognizing the drawstring 192. As shown in the inset of FIG. 29, the endoscope 600 can be used to guide the mounting feature portion 340 and mount the mounting feature portion 340 to the drawstring 192.

FIG. 30 shows a mounting feature 340 mounted on the drawstring 192. After attaching the mounting feature 340 to the drawstring 192, the mounting feature 340 can be stowed in the hook sheath 222 by pulling the second end 312 of the hook cable 220 (shown in FIG. 9A). By pulling the second end 312 of the hook cable 220 while keeping the hook sheath 222 in place, the mounting feature 340 is housed in the hook sheath 222 and the drawstring 192 is also carried into the hook sheath 222. Since the first end portion 320 of the hook sheath 222 is too thin, the base end portion 130 of the anchor 110 cannot enter the hook sheath 222 while taking an extended configuration. Further pulling the drawstring 192 into the hook sheath 222 pulls the drawstring 192 away from the proximal portion 130, which reduces the size of the proximal portion 130. The drawstring 192 can be further pulled out of the anchor 110, which further crushes the proximal portion 130 until the proximal portion 130 transitions to the reduced configuration.

FIG. 31 shows a lock sheath 354 advancing along the hook cable 220 towards the second end 322 of the hook sheath 222. In some examples, the hook cable 220 and the hook sheath 222 can be locked together to prevent them from moving longitudinally with respect to each other. In some examples, the hook cable 220 and hook sheath 222 are formed as a single integrated structure and may include a hook assembly 210. In some examples, the hook cable lock 350 can be used to lock both the hook cable 220 and the hook sheath 222 to form the hook assembly 210. As already described with reference to FIG. 9, in some embodiments, the lock sheath 354 is used to further the hook cable 220 into the hook sheath 222 towards the second end 322 of the hook sheath 222. It is possible to prevent moving forward. In some embodiments, the endoscope 600 can be removed from the patient. The endoscope 600 can be removed from the patient, leaving the hook assembly 210 in place within the patient.

FIG. 32 shows that the second end 312 of the hook cable 220 left outside the patient's body is inserted into the capsule assembly 212. The hook cable 220 can be inserted into the capsule assembly 212 by inserting the second end 312 of the hook cable 220 into the first end 410 of the capsule 230. After the hook cable 220 is inserted into the capsule assembly 212, the capsule assembly 212 can be inserted inside the patient and advanced until it reaches the proper position. The capsule assembly 212 is guided into place by advancing the capsule assembly 212, which covers the hook cable 220 attached to the anchor 110, which is still in place inside the patient. The capsule assembly 212 can be inserted into the patient by advancing the capsule assembly 212 along the outer surface of the hook assembly 210. That is, the hook assembly 210 can be kept stationary, while the capsule assembly 212 advances in the patient's body while advancing around the hook assembly 210. In this way, the capsule assembly is guided to a position adjacent to the anchor 110.

FIG. 33 shows a capsule assembly 212 that is placed inside the patient and surrounds the hook cable 220. The capsule assembly 212 is in place within the patient and the hook assembly 210 is attached to the drawstring 192. As shown in the inset of FIG. 28, once the capsule assembly 212 is in place, the hook assembly lock 580 can be engaged to lock the hook assembly 210 longitudinally with respect to the capsule assembly 212. .. As already described with reference to FIG. 21B, rotating the cap 582 of the hook assembly lock 580 reduces the inner diameter of the second end 532 of the third sheath 444. By reducing the inner diameter of the second end 532 of the third sheath 444 with the hook cable stopper 360 inside the hook assembly lock 580, the third sheath and the hook cable 220 are both locked and the hook cable 220. Is locked to the second end 532 of the third sheath 444. It also connects the hook assembly 210 and the capsule assembly 212 longitudinally with respect to each other. In some embodiments, the endoscope can be reinserted into the patient for visibility by the healthcare professional.

FIG. 34 shows that the second control knob 438 rotates with respect to the central core 440. As already described with reference to FIGS. 22A and 22B, rotation of the second control knob 438 causes the second end 532 of the third sheath 444 to move relative to the central core 440. The second control knob 438 can be rotated to extend the second end 532 of the third sheath 444 away from the central core 440 to extend the length of the handle 234. As shown in FIG. 34, the first end 510 of the second sheath 442 is attached to the capsule shaft 232, while the capsule shaft 232 is attached to the capsule 230. The hook sheath 222, the capsule shaft 232 and the capsule 230 are incompressible, and the hook assembly 210 is attached to the second end 532 of the third sheath 444, so that the third sheath 444 is the first. The hook assembly 210 is pulled through the capsule shaft 232 by extending the end 532 of 2 away from the central core 440. As a result, the hook cable 220 further pulls the drawstring 192 into the hook sheath 222, and the base end portion 130 of the anchor 110 is crushed. The hook cable 220 can be pulled into the hook sheath 222 until the base end portion 130 is completely crushed.

FIG. 35 shows that the base end portion 130 of the anchor 110 is crushed and aligned with the capsule 230. When the proximal portion 130 of the anchor 110 is crushed, the proximal portion 130 can be retracted into the capsule 230. FIG. 36 shows that the proximal flange is completely contained within the capsule 230 and the capsule 230 penetrates the patient's pylorus. After the proximal flange is crushed, the neck portion of the anchor 110 can be pulled into the capsule 230. Further, by rotating the first control knob 436, the second sheath 442 extends away from the central core 440 and the capsule 230 is pushed to cover the anchor 110. As shown in FIG. 37, the capsule 230 can be further advanced until it presses against the tip portion 132 and crushes the tip portion 132. As shown in FIG. 38, the entire anchor 110 can be pulled into the capsule 230. The anchor 110 has a completely collapsed configuration, and the gastrointestinal device 100 can be taken out from the inside of the patient while being housed inside the capsule 230. As shown in FIG. 39, the gastrointestinal device 100 can be taken out from the inside of the patient by pulling out the take-out device 200 from the patient.

The devices and methods described herein can be used to remove the gastrointestinal device from inside the patient. In some embodiments, the devices and methods disclosed herein can be used to remove various foreign bodies from inside the patient. Typically, the device includes a fitting or fixing device for attaching to an object such as a drawstring attached to a gastrointestinal anchor. The fitting or fixing device can be retracted into the capsule or lumen, which reduces the overall size of the foreign body to facilitate removal of the foreign body. When a fixture or fixture is attached to or surrounds a foreign object, the capsule or lumen can advance to cover the object.

In some embodiments, the apparatus disclosed herein provides a rigid shaft that can withstand significant compressive forces without deformation. The apparatus disclosed herein also provides a mechanism for drawing foreign matter into a protective luminal device that facilitates removal of the foreign matter. The embodiments disclosed herein provide a cable for a mounting feature and a means of exerting a longitudinal force between the cable and the protective luminal device. The handle structure and shaft properties disclosed herein allow the user to exert a significant amount of force to pull the hook into the capsule. The handles disclosed above can be used to apply extremely high tensile forces to the cable using shallow pitch threads. That is, the structure disclosed herein allows the handle to implement a thread with a shallow pitch angle, which transmits a large force to allow the user to encapsulate the hook. It allows for pulling in and requires only a relatively small circumferential force to rotate the screw. With proper screw pitch, you can get a handle that can provide a high lever effect over each rotation of the control knob. Accordingly, the devices and methods disclosed herein provide a removal device capable of transmitting a high tensile force to recover a foreign body from inside the patient.

In some embodiments, the devices and methods disclosed herein are endoscopes capable of delivering and / or removing a medical device to a patient's gastrointestinal tract with minimal trauma to the gastrointestinal tract. Provide a target extraction system. The delivery and / or removal system can include an apical capsule that holds the implant, a sleeve delivery catheter that follows over the guide wire, and a handle for deploying the implant. The removal system can use a through-the-scope (TTS) removal catheter that engages the drawstring attached to the implant. When the implant engages, the scope is removed and a second catheter with an apical capsule advances over the TTS catheter to retract the implant into the capsule. When the implant is completely retracted into the catheter, the implant is removed. In some embodiments, the delivery or retrieval method requires less than 25 minutes to carry out.

Various modifications and additions to the exemplary embodiments described may be made without departing from the scope of the invention. For example, although the above embodiments refer to specific features, the scope of the invention may also include embodiments having various combinations of features and embodiments that may not include all of the above features. ..

Claims (12)

A hook assembly having a first end portion, a second end portion, and a length portion between them, and having a mounting feature portion at the first end portion.
An extraction device that includes a capsule assembly, wherein the capsule assembly comprises a capsule, a capsule shaft, and a handle that are connected in series and define an inner peripheral hole along the length of the capsule assembly along the central longitudinal axis. Including, the capsule has a first end defining an opening to the inside of the capsule and an inner peripheral hole of the capsule assembly configured to slidably accept the hook assembly.
The handle has a central portion, a first extension portion defining a first end of the handle and having a first end attached to the capsule shaft, and a second end of the handle. The second extension has a hook assembly lock at the second end and the handle is the first. A storage configuration in which the end is at a first distance from the second end along the central longitudinal axis and the first end is second from the second end along the central longitudinal axis. Has an extended configuration at a distance of
The hook assembly lock is configured to lock the hook assembly to the second extension, which pulls the hook assembly relative to the capsule shaft along the central longitudinal axis. And the first extension is configured to push the capsule shaft against the hook assembly along the central longitudinal axis .
The handle has a first control knob configured to shift the first extension portion between the storage configuration and the extension configuration, and the second extension portion has the storage configuration and the extension configuration. A take-out device , further comprising a second control knob configured to transition to and from . The take-out device according to claim 1, wherein the mounting feature portion is a hook. The ejector according to claim 1, wherein the capsule assembly is incompressible along the central longitudinal axis. The second end of the capsule is attached to the first end of the capsule shaft, and the second end of the capsule shaft is attached to the first end of the first extension. The take-out device according to claim 1. The take-out device according to claim 1, wherein the capsule includes a close contact coil. The extraction device according to claim 1, wherein the capsule is flexible so as to bend at an angle with respect to the central longitudinal axis. The ejecting device according to claim 1, wherein the capsule is configured to receive a medical device inside the capsule. The take-out according to claim 1 , wherein the first control knob and the second control knob are configured to convert a rotational movement between the hook assembly and the capsule shaft into a longitudinal linear movement. Device. The extraction device according to claim 1, wherein the handle is configured to pull the mounting feature into the first end of the capsule while the medical device is mounted to the mounting feature. The take-out device according to claim 1, wherein the medical device is configured to shift from an expanded configuration to a collapsed configuration and to pull the medical device into the capsule in the collapsed configuration. The ejecting device according to claim 1, further comprising a tip on the first end of the capsule, wherein the tip is configured to removably cover an opening into the capsule. The ejector according to claim 1, wherein the unloading device is configured to provide about 22.2 Newtons to about 155.7 Newtons along the central longitudinal axis between the hook assembly and the capsule shaft.

Images